Bosma Enterprises 72-10501
GUDID 30818634020186
Nitrile Textured Powder Free Exam Gloves Small 100/Box
Bosma Enterprises
Nitrile examination/treatment glove, non-powdered, non-antimicrobial| Primary Device ID | 30818634020186 |
| NIH Device Record Key | 4b815906-4e1f-477a-950f-1a08b07af88d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bosma Enterprises |
| Version Model Number | 72-10501 |
| Catalog Number | 72-10501 |
| Company DUNS | 878070325 |
| Company Name | Bosma Enterprises |
| Device Count | 100 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 800-362-5463 |
| kimm@bosma.org | |
| Phone | 800-362-5463 |
| kimm@bosma.org | |
| Phone | 800-362-5463 |
| kimm@bosma.org | |
| Phone | 800-362-5463 |
| kimm@bosma.org | |
| Phone | 800-362-5463 |
| kimm@bosma.org | |
| Phone | 800-362-5463 |
| kimm@bosma.org | |
| Phone | 800-362-5463 |
| kimm@bosma.org | |
| Phone | 800-362-5463 |
| kimm@bosma.org | |
| Phone | 800-362-5463 |
| kimm@bosma.org | |
| Phone | 800-362-5463 |
| kimm@bosma.org | |
| Phone | 800-362-5463 |
| kimm@bosma.org | |
| Phone | 800-362-5463 |
| kimm@bosma.org | |
| Phone | 800-362-5463 |
| kimm@bosma.org | |
| Phone | 800-362-5463 |
| kimm@bosma.org | |
| Phone | 800-362-5463 |
| kimm@bosma.org | |
| Phone | 800-362-5463 |
| kimm@bosma.org | |
| Phone | 800-362-5463 |
| kimm@bosma.org |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight, fluorescent lighting, x-rays, moisture and ozone |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight, fluorescent lighting, x-rays, moisture and ozone |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight, fluorescent lighting, x-rays, moisture and ozone |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight, fluorescent lighting, x-rays, moisture and ozone |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight, fluorescent lighting, x-rays, moisture and ozone |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight, fluorescent lighting, x-rays, moisture and ozone |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight, fluorescent lighting, x-rays, moisture and ozone |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight, fluorescent lighting, x-rays, moisture and ozone |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight, fluorescent lighting, x-rays, moisture and ozone |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight, fluorescent lighting, x-rays, moisture and ozone |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight, fluorescent lighting, x-rays, moisture and ozone |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight, fluorescent lighting, x-rays, moisture and ozone |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight, fluorescent lighting, x-rays, moisture and ozone |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight, fluorescent lighting, x-rays, moisture and ozone |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight, fluorescent lighting, x-rays, moisture and ozone |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight, fluorescent lighting, x-rays, moisture and ozone |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight, fluorescent lighting, x-rays, moisture and ozone |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00818634020185 [Unit of Use] |
| GS1 | 20818634020189 [Primary] |
| GS1 | 30818634020186 [Package] Contains: 20818634020189 Package: Case [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K042226
FDA Product Code
| LZA | Polymer Patient Examination Glove |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-12 |
| Device Publish Date | 2021-07-02 |
On-Brand Devices [Bosma Enterprises]
| 30818634020179 | Nitrile Textured Powder Free Exam Gloves Extra Small 100/Box |
| 10818634020618 | Accelerate-OR ML Kit-Infection Control Kit; Each Kit Includes Quicksuite kit, 40x40 Clear Draw T |
| 60818634020088 | Latex Textured Powder Free Exam Gloves Small 100/Box |
| 40818634020114 | Latex Textured Powder Free Exam Gloves Extra Large 100/Box |
| 40818634020107 | Latex Textured Powder Free Exam Gloves Large 100/Box |
| 40818634020077 | Latex Textured Powder Free Exam Gloves Extra Small 100/Box |
| 40818634020091 | Latex Textured Powder Free Exam Gloves Medium 100/Box |
| 30818634020216 | Nitrile Textured Powder Free Exam Gloves Extra Large 100/Box |
| 30818634020209 | Nitrile Textured Powder Free Exam Gloves Large 100/Box |
| 30818634020193 | Nitrile Textured Powder Free Exam Gloves Medium 100/Box |
| 30818634020186 | Nitrile Textured Powder Free Exam Gloves Small 100/Box |
| 20818634020066 | Vinyl Powder Free Exam Gloves Extra Large 100/Box |
| 20818634020059 | Vinyl Powder Free Exam Gloves Large 100/Box |
| 20818634020042 | Vinyl Powder Free Exam Gloves Medium 100/Box |
| 20818634020035 | Vinyl Powder Free Exam Gloves Small 100/Box |
| 20818634020028 | Vinyl Powder Free Exam Gloves Extra Small 100/Box |
| 10818634025002 | FSSA PPE Kit; Each Kit Includes Large Nitrile Exam Glove (10), and Large Alcohol Prep Pad (5). |
| 10818634024869 | Wounded Warrior PPE Kit-XLarge; Each Kit Includes XLarge Nitrile Exam Glove (2), 2 oz Scented Ha |
| 10818634024852 | Wounded Warrior PPE Kit-Large; Each Kit Includes Large Nitrile Exam Glove (2), 2 oz Scented Hand |
| 10818634024845 | Wounded Warrior PPE Kit-Medium; Each Kit Includes Medium Nitrile Exam Glove (2), 2 oz Scented Ha |
| 10818634024838 | Wounded Warrior PPE Kit-Small; Each Kit Includes Small Nitrile Exam Glove (2), 2 oz Scented Hand |
| 10818634024821 | Accelerate-OR DEN Kit; Each Kit Includes QuickSuite Kit, and STAT-BLOC Disposable Antimicrobial |
| 10818634020908 | Hygiene Kit; Each Kit Includes Comb, 2 oz Mouthwash, 4 oz Shampoo/Body Wash, .85 oz Shaving Crea |
| 10818634020892 | Shelter in Place and Hygiene Combo Kit; Each Kit Includes 40x80 Disposable Grey Poly Blanket, 13 |
| 10818634020885 | Shelter in Place NH Kit; Each Kit Includes 40x80 Disposable Grey Poly Blanket, 40x60 Disposable |
| 10818634020878 | Shelter in Place NE Kit; Each Kit Includes 40x80 Disposable Grey Poly Blanket, 40x60 Disposable |
| 10818634020861 | Shelter in Place Kit; Each Kit Includes 40x80 Disposable Grey Poly Blanket, 40x60 Disposable Whi |
| 10818634020854 | Endoscopy ORE Kit; Each Kit Includes Draw String Tote, 32 oz Bowl, 16 oz Bowl, 4x4 Gauze PRM (20 |
| 10818634020847 | Patient Transportation PTH Kit; Each Kit Includes STAT-BLOC Disposable Premium Antimicrobial Imp |
| 10818634020830 | Patient Transportation PTD Kit; Each Kit Includes STAT-BLOC Disposable Antimicrobial Impervious |
| 10818634020823 | Patient Transportation PDA Kit; Each Kit Includes STAT-BLOC Disposable Premium Antimicrobial Imp |
| 10818634020816 | Ambulance Pack Washington DC Kit; Each Kit Includes 40x80 Disposable Grey Poly Blanket, 40x80 Di |
| 10818634020809 | Accelerate-OR Dental SED Kit; Each Kit Includes 40x40 Red Infectious Waste 2 mil Draw Tape Bag, |
| 10818634020793 | Accelerate-OR Lithotomy Suite SEL Kit; Each Kit Includes Lithotomy Suite Kit, 40x60 Sahara OR Ta |
| 10818634020786 | Accelerate-OR Lithotomy Suite SAL Kit; Each Kit Includes Lithotomy Suite Kit, 40x40 Clear 2 mil |
| 10818634020779 | Accelerate-OR Cysto ORL Kit; Each Kit Includes Lithotomy Suite Kit, 40x40 Clear 2 mil Draw Tape |
| 10818634020762 | Accelerate-OR Lithotomy Suite MU Kit; Each Kit Includes Lithotomy Suite Kit, 40x40 Clear 2 mil D |
| 00818634020758 | Accelerate-OR Cath & EP LRC Kit; Each Kit Includes QuickSuite Kit, 60x78 Patient Lift Sheet, 40x |
| 10818634020748 | Accelerate-OR Lithotomy Suite HUL Kit; Each Kit Includes Lithotomy Suite Kit, 40x40 Clear 2 mil |
| 10818634020731 | Accelerate-OR Lithotomy Suite DCL Kit; Each Kit Includes Lithotomy Suite Kit, 40x40 Clear 2 mil |
| 10818634020724 | Accelerate-OR Lithotomy DNL Kit; Each Kit Includes Lithotomy Suite Kit, 40x60 Sahara OR Table Sh |
| 10818634020717 | Accelerate-OR Lithotomy CIL Kit; Each Kit Includes 40x60 Sahara OR Table Sheet 20" Absorb (2), a |
| 10818634020700 | Accelerate-OR Interventional Radiology BX2 Kit; Each Kit Includes QuickSuite Kit, 40x40 Clear 2 |
| 10818634020694 | Accelerate-OR SPO Kit; Each Kit Includes QuickSuite Kit, 40x40 Clear 2 mil Draw Tape Bag (2), an |
| 00818634020680 | Accelerate-OR SEO Kit; Each Kit Includes QuickSuite Kit, 40x40 Red Infectious Waste 2 mil Draw T |
| 10818634020670 | Accelerate-OR SDO Kit; Each Kit Includes 40x70 Butterfly Draw Sheet, Sahara Grippy Table Sheet, |
| 10818634020663 | Accelerate-OR SAO Kit; Each Kit Includes QuickSuite Kit, 40x40 Clear 2 mil Draw Tape Bag, 38x41 |
| 10818634020656 | Accelerate-OR RIO Kit; Each Kit Includes QuickSuite Kit, 40x40 Clear 2 mil Draw Tape Bag (2), 40 |
| 10818634020649 | Accelerate-OR R Kit; Each Kit Includes QuickSuite Kit, 40x40 Clear 2 mil Draw Tape Bag (2), 40x4 |
| 10818634020625 | Accelerate-OR Lithotomy Suite PAL Kit; Each Kit Includes Lithotomy Suite Kit, 40x40 Clear 2 mil |
Trademark Results [Bosma Enterprises]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BOSMA ENTERPRISES 87215784 5226945 Live/Registered |
Bosma Industries for the Blind, Inc. aka Bosma Enterprises 2016-10-26 |
 BOSMA ENTERPRISES 87215783 5217528 Live/Registered |
Bosma Industries for the Blind, Inc. 2016-10-26 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.