510(k) K110102
- Device
- POWDERFREE NITRILE EXAMINATION GLOVES COATED WITH ALLOGEL,COLORS BLUE,MAGNETA,COPPER AND WITHOUT ALLOGEL,COLORS BLUE,MAG
- Applicant
- PREVENTIVE CARE, INC.
- 510(k) number
- K110102
- Product code
- LZA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-05-13
- Date received
- 2011-01-13
- Regulation
- 880.6250
- Classification name
- Polymer Patient Examination Glove
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANIL SEGAT
- Address
- 15215 Boulder Trl. Rosemount MN US 55068 55068
FDA Registration Numbers#
- 3036781051
- 2939935
- 3011649314
- 3010220595
- 9613494
- 3006789222
- 2183301
- 3004111573
- 3004995451
- 3010436932
- 3021206557
- 9616896
- 3015335034
- 3038592309
- 3003199637
- 3012304897
- 3045062172
- 3042365317
- 3011689956
- 3027601983
- 3021286079
- 3008298053
- 3012446547
- 3004553390
- 3009243435
- 3012924721
- 3017610877
- 3013428737
- 3021206556
- 3014579161
- 3036773438
- 3009659860
- 3013546437
- 3004513970
- 3030671502
- 1833700
- 3010864832
- 3015729128
- 3007707004
- 3038276731
- 3003120666
- 3008076203
- 3008496560
- 3010966951
- 3043650518
- 3038277359
- 1055236
- 1928237
- 3022953895
- 3015422337
- 1319302
- 3030582179
- 3016785252
- 3014384460
- 3008253024
- 3007407626
- 3010175289
- 3034669683
- 2431014
- 1423537
- 3021827562
- 3032026388
- 3004950768
- 3021841055
- 2024980
- 3013496867
- 3030419987
- 3008427684
- 3020521811
- 3014421917
- 1219821
- 3014164734
- 3038284237
- 3010811068
- 2939388
- 3006979699
- 3010402691
- 1250045
- 3008509176
Source Documents#
Other 510(k) Records For Product Code LZA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252117 | Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution | Sw Technologies, Inc. | 2026-06-24 |
| K253824 | Powder Free Nitrile Examination Gloves Non-Sterile Black | Kanglongda Vietnam Protection Technology Company Limited | 2026-06-18 |
| K260867 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black) | Hartalega NGC Sdn. Bhd. | 2026-06-17 |
| K260806 | Nitrile Disposable Examination Gloves | Vista Industries,, LLC | 2026-06-03 |
| K260703 | Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl | S&S Glove Corporation | 2026-06-03 |
| K253160 | Syntex Exam Gloves | Basic Medical Technology, Inc. | 2026-01-23 |
| K252549 | Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid | Kossan International Sdn Bhd | 2026-01-13 |
| K251141 | Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Mercator Medical (Thailand), Ltd. | 2025-11-17 |
| K250861 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black) | Hartalega NGC Sdn. Bhd. | 2025-10-23 |
| K252075 | Program insite® Powder-Free, Disposable Nitrile Exam Gloves | Program Insite, LLC | 2025-10-17 |
| K251716 | Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate | Basic Medical Technology, Inc. | 2025-08-27 |
| K252244 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid | Ever Global (Vietnam) Enterprise Corporation | 2025-08-21 |
| K243604 | Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid | O&M Halyard, Inc. | 2025-08-18 |
| K251319 | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff | Hartalega NGC Sdn. Bhd. | 2025-07-30 |
| K250193 | Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue) | Basic Medical Technology, Inc. | 2025-07-09 |
Legacy Summary#
summary
FDA Review#
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