510(k) K250193
- Device
- Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue)
- Applicant
- Basic Medical Technology, Inc.
- 510(k) number
- K250193
- Product code
- LZA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-07-09
- Date received
- 2025-01-23
- 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
- N
Related Records
Applicant Contact
- Contact
- Zhao John
- Address
- 5300 Concours St. Ontario CA US 91764 91764
FDA Registration Numbers
- 3003895865
- 3042940407
- 3012314549
- 3021286079
- 3019769825
- 3005621729
- 3042956952
- 3008298053
- 1043549
- 3012441043
- 3013188547
- 3007829481
- 9615978
- 3015140351
- 3019585047
- 3030447506
- 3008395508
- 9617444
- 1423537
- 9610861
- 3019944216
- 2437780
- 3012711490
- 3003887292
- 3038277359
- 3031590640
- 3004577220
- 3000247873
- 9613998
- 3031181949
- 3003823770
- 3015142965
- 2214133
- 3011209798
- 8040653
- 3010201834
- 3023272672
- 3022543478
- 3021233711
- 3014593437
- 3017509841
- 3015128453
- 3010363542
- 3028652705
- 3014579161
- 3010436932
- 3020521811
- 3030470903
- 3009118264
- 3013034812
- 3009538921
- 3014743234
- 1937310
- 3008496560
- 3008261717
- 3023917
- 3003699698
- 1000266564
- 8041108
- 3008384335
- 3005558160
- 3002661124
- 3011189071
- 3032579548
- 3024999439
- 3016761372
- 3012034017
- 3012104670
- 3009243435
- 3014683120
- 3015875006
- 3005024009
- 3038718579
- 1119294
- 3010194621
- 3013565389
- 3010830834
- 3005024094
- 1000254914
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 |
| 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 |
| K243796 | GLOVEONE Powder-Free Nitrile Examination Gloves Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl] | Glove One, LLC | 2025-06-03 |