510(k) K220491
- Device
- Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs
- Applicant
- Hainan Asther Medical Equipment Co., Ltd.
- 510(k) number
- K220491
- Product code
- LZC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-05-14
- Date received
- 2022-02-22
- Regulation
- 880.6250
- Classification name
- Medical Glove, Specialty
- 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
- Viki Ye
- Address
- 503 Rm., 5th Floor, B03, Hainan Ecological Software Park, Old Town Chengmai CN 571900 571900
FDA Registration Numbers#
- 3005060582
- 3015173212
- 1319302
- 3016785252
- 1423537
- 3022953895
- 3016685880
- 3026363353
- 3021591322
- 3009229300
- 3006552561
- 3038276166
- 3033715710
- 1928237
- 9680466
- 9613998
- 3021206557
- 1063851
- 3011211126
- 3016844398
- 3014268334
- 3010201834
- 3019585047
- 2028805
- 3007289408
- 3025231442
- 3004553390
- 3036773438
- 3030470903
- 1000266564
- 3007842585
- 3019252794
- 1833700
- 3015219124
- 3014269027
- 1000121056
- 3005568780
- 3008604557
- 3006796582
- 3016601021
- 3005632797
- 3015997711
- 8041150
- 8043736
- 2032521
- 9616088
- 3009055041
- 3010966951
- 3009538921
- 3010194621
- 3005022483
- 1054241
- 3011189071
- 9610406
- 3017610877
- 3012354669
- 3008058446
- 3015335034
- 3013514660
- 3016413634
- 3019798835
- 3023272672
- 3012034017
- 3002807090
- 3001970230
- 3013546437
- 3038592309
- 2939935
- 3034618336
- 3014847584
- 9611959
- 3010220595
- 3012429634
- 3013565389
- 3038187455
- 3003199637
- 9681163
- 9615914
- 3021286079
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LZC#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252313 | Cardinal Health Nitrile Examination Gloves Extended Cuff | Cardinalhealth | 2026-01-14 |
| K243959 | Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs | Lingshi Hongruida Health Protection Technology Co., Ltd. | 2025-02-24 |
| K221157 | JR Medic | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2022-08-30 |
| K222449 | Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) | Better Care Plastic Technology Co., Ltd. | 2022-08-27 |
| K220545 | Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs | Hl Rubber Industries Sdn Bhd | 2022-05-26 |
| K220353 | Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs | Niujian Technology Co., Ltd. | 2022-03-31 |
| K213910 | Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy Drugs | Changzhou Universal Medical Equipment Co., Ltd. | 2022-03-10 |
| K213325 | Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs | Anhui Xinyisheng Medical Technology Co.,Ltd | 2022-01-28 |
| K213076 | AspenMed+ | Aspen Glove Sdn. Bhd. | 2021-12-20 |
| K212639 | Disposable Medical Nitrile Examination Gloves (Non sterile) | Jiangsu Nanfang Medical Co., Ltd. | 2021-12-08 |
| K212827 | Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2021-12-06 |
| K200633 | Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove | 0 & M Halyard, Inc. | 2020-10-11 |
| K201390 | Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs) | Medline Industires, Inc. | 2020-09-18 |
| K193555 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate | Ever Global (Vietnam) Enterprise Corp | 2020-06-04 |
| K191230 | Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves | O&M Halyard, Inc. | 2019-11-08 |