AmerisourceBergen

GUDID 80368001109129

Vinyl Exam Gloves Stretch Powder Free (X-Large)

BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY

Vinyl examination/treatment glove, non-powdered

• Primary Device ID: 80368001109129
• NIH Device Record Key: ff4e1ea5-60ff-417c-9642-b1b58e1679ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AmerisourceBergen
• Version Model Number: 10912
• Company DUNS: 985523874
• Company Name: BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY
• Device Count: 130
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00368001109123 [Primary]
GS1	60368001109125 [Package]; Contains: 00368001109123; Package: Case [10 Units]; In Commercial Distribution
GS1	80368001109129 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112266

FDA Product Code

• LYZ: Vinyl 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: 2022-07-18
• Device Publish Date: 2022-07-08

On-Brand Devices [AmerisourceBergen]

• 60368001110039: Thermometer probe covers
• 60368001110022: Digital Thermometer, waterproof - Flexible Tip
• 60368001110015: Digital Thermometer, waterproof - Rigid Tip
• 60368001105424: FACE MASK WITH VISOR Level 3, PROCEDURE EAR LOOP - ANTI FOG & GLARE - BLUE
• 60368001105417: FACE MASK Level 3, SURGICAL TIE, ANTI FOG FOAM, BLUE
• 60368001105400: FACE MASK Level 3, PROCEDURE EAR LOOP, BLUE
• 00368001105392: FACE MASK Level 2, SURGICAL TIE, SOFT BILL, DENIM BLUE
• 60368001105387: Face Mask Level 1 Procedure Earloops Blue
• 60368001105370: Face Mask Level 1, Cool & Light Surgical Tie-Blue
• 80368001100416: NITRILE EXAM GLOVE
• 80368001100447: Nitrile Exam Glove Extra Large
• 80368001100430: Nitrile Exam Glove Large
• 80368001100423: Nitrile Exam Glove Medium
• 60368001100405: Latex Exam Glove Extra Large
• 60368001100399: Latex Exam Glove Large
• 60368001100382: Latex Exam Glove Medium
• 60368001100375: Latex Exam Glove Small
• 20368001105464: Face Mask with Earloops Blue, Anti-Fog Level 3
• 20368001105457: Face Mask with Ties Blue with Pattern, Soft Bill Level 2
• 80368001105442: Face Mask with Ties Light Blue Level 1
• 80368001105435: Face Masks with Ear Loops Light Blue Level 1
• 80368001105480: Face Mask with Ties Blue Anti-Fog Level 3
• 60368001115027: Fecal Loops Disposable Pediatric Size
• 80368001115014: Fecal Loops Disposable Adult Size
• 80368001112075: Laparotomy Sponges Non-sterile pre washed 18" X 18"
• 80368001112068: Laparotomy Sponges Non-sterile, Pre-washed 4" X 18"
• 80368001103448: Conforming Stretch Gauze Bandage Sterile
• 60368001103437: Gauze Fluff Bandage Roll Non-Sterile
• 60368001112101: Laparotomy Sponges X-Ray Detectable Pre-washed Sterile
• 60368001112095: Laparotomy Sponges X-Ray Detectable Pre-washed Sterile
• 80368001112082: Laparotomy Sponges X-Ray Detectable Pre-washed Sterile
• 80368001100492: Nitrile Exam Gloves Black (XX Large)
• 60368001100481: Nitrile Exam Gloves Black (X-Large)
• 60368001100474: Nitrile Exam Gloves Black (L)
• 80368001100461: Nitrile Exam Gloves Black (M)
• 80368001100454: Nitrile Exam Gloves Black (S)
• 80368001102823: Porous Tape (1/2in x 11yd)
• 60368001102812: Porous Tape (2in x 11yd)
• 60368001102799: Waterproof Adhesive Tape (2in x 10yd)
• 80368001102786: Waterproof Adhesive Tape (1in x 10yd)
• 60368001102188: Porous Tape (1in x 11yd)
• 60368001102553: Cohesiant Wrap 4 in X 5 yd (Assorted Pack Primary) (Blue, Red, Yellow)
• 60368001102539: Cohesiant Wrap 4 in X 5 yd (Assorted Pack Bold) (Bold Hunter Green, Purple, Blue)
• 60368001102508: Cohesiant Wrap 4 in X 5 yd (Assorted Pack Bright) (Bright Blue, Green, Yellow)
• 60368001102492: Cohesiant Wrap 4 in X 5 yd (Assorted Pack Fluorescent) (Fluorescent Green, Fluorescent Pink, Flu
• 60368001102485: Cohesiant Wrap 2 in X 5yd (Assorted Pack Primary) (Blue, Red, Yellow)
• 60368001102461: Cohesiant Wrap 2 in X 5 yd (Assorted Pack Bright) (Bright Blue, Green, Yellow)
• 60368001102447: Cohesiant Wrap 2 in X 5yd (Assorted Pack Bold) (Bold Hunter Green, Purple, Blue)
• 60368001102430: Cohesiant Wrap 2 in x 5 yd (Assorted Pack Fluorescent) (Fluorescent Green, Fluorescent Pink, Flu
• 20368001102777: Cohesiant Wrap 4 in X 5 yd (Blue)