510(k) K241780
- Device
- Cardinal Health Nitrile Exam Gloves
- Applicant
- Cardinal Health200, LLC
- 510(k) number
- K241780
- Product code
- LZA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-08-23
- Date received
- 2024-06-20
- Regulation
- 880.6250
- Classification name
- Polymer Patient Examination Glove
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Vani Bala
- Address
- 3651 Birchwood Dr. Waukegan IL US 60085 60085
FDA Registration Numbers
- 1319302
- 1423537
- 3016685880
- 3021591322
- 3009229300
- 1063851
- 9680466
- 3034669683
- 2954902
- 3030470903
- 1833700
- 3010147274
- 3015477649
- 3008604557
- 3015997711
- 8041150
- 3007471500
- 3011427127
- 1054241
- 3024712919
- 1928237
- 3005558160
- 3012924721
- 3008261717
- 3020831613
- 3004113569
- 9611959
- 1220477
- 3012429634
- 3021286079
- 1121142
- 3013037032
- 3020984755
- 3010864832
- 3042956952
- 3017207705
- 3015412466
- 3013451367
- 8041120
- 3015128453
- 8040818
- 3019769825
- 3008509176
- 3008489813
- 3036781051
- 3005322833
- 3011279497
- 3006789222
- 1038758
- 3017509841
- 3017171460
- 3009474977
- 3029901632
- 3042365317
- 3008840959
- 3009503464
- 9710583
- 3022407383
- 3013034812
- 3009964047
- 3011050560
- 9681660
- 3014384460
- 3012104670
- 3010605427
- 3017887964
- 8041108
- 3015875006
- 3013530281
- 2938651
- 3008496560
- 9616501
- 1000254914
- 2086655
- 2183301
- 3017114229
- 3003823770
- 2939821
- 3008384335
Source Documents
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LZA
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K250342 | Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl | Encompass Industries Sdn. Bhd. | 2025-07-08 |
| K250496 | Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White) | Zibo Shengkun Chemical Industry Co., Ltd. | 2025-07-07 |
| K243172 | Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles | O&M Halyard, Inc. | 2025-06-18 |
| K243133 | Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid | Kl-Kepong Rubber Products Sdn. Bhd. | 2025-06-17 |
| K243694 | Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue | Mah Sing Healthcare Sdn. Bhd. | 2025-06-06 |