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#
- 3022407383
- 3008253024
- 8041150
- 3005024009
- 3015997711
- 9681163
- 3005024094
- 3021841055
- 3021233711
- 3008509176
- 3028652705
- 3038276166
- 3012304897
- 3042956952
- 1058397
- 9611959
- 3018779144
- 3010966951
- 3013298431
- 8041120
- 3038592309
- 3014579161
- 2648727
- 3015058854
- 3008058446
- 3021641087
- 3010864832
- 3010419931
- 3015727296
- 3009538921
- 3005099803
- 9680622
- 3012354669
- 3006552561
- 3036774599
- 3009496643
- 3010582952
- 9680466
- 9616501
- 3010602489
- 3005595283
- 1000254914
- 2086655
- 3026062711
- 3022953895
- 3014268334
- 3015173212
- 3010605427
- 3008604557
- 3020521811
- 3019849096
- 3021591319
- 3015335977
- 8041003
- 3013037032
- 3017616393
- 9710583
- 3009503464
- 2028805
- 3042940407
- 3011189071
- 3008700497
- 3019798835
- 3021286079
- 3024755882
- 1649518
- 1063851
- 1319302
- 3018507299
- 3004995451
- 3007289408
- 3013514660
- 3016413634
- 8040614
- 3021015522
- 3015128453
- 3027977504
- 9616088
- 3004553390
- 3001970230
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 |