510(k) K222129
- Device
- Nitrile Examination Powder Free Glove, Blue Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim, Nitrile Examination Powder Free Glove, Black Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance
- Applicant
- Top Glove Medical (Thailand) Co., Ltd.
- 510(k) number
- K222129
- Product code
- LZA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-02-10
- Date received
- 2022-07-18
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Shahana Parveen Binti Ridzam Shah
- Address
- 188, 189, 190 Moo 5 Kanchanawanich Rd., Tambol Sumnakkhan Amphur Sadao TH 90320 90320
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 |