510(k) K193555
- Device
- Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate
- Applicant
- Ever Global (Vietnam) Enterprise Corp
- 510(k) number
- K193555
- Product code
- LZC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-06-04
- Date received
- 2019-12-20
- Regulation
- 880.6250
- Classification name
- Patient Examination Glove, Specialty
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jerry Lin
- Address
- Long Thanh Industrial Zone Taman Village Dong Nai Province VN 810000 810000
FDA Registration Numbers#
- 3001970230
- 3004704697
- 3012421607
- 3011089435
- 2028805
- 9616088
- 3007502227
- 8041108
- 3013514660
- 8041005
- 3011649314
- 2183301
- 1000254914
- 3012304897
- 3021206556
- 3038277359
- 3017114229
- 3018779144
- 3006552561
- 3022543478
- 3022953895
- 3013428737
- 3002806603
- 3014268334
- 2939935
- 3015727296
- 3018507299
- 3038592309
- 3030447506
- 3045079147
- 3007327603
- 3021591322
- 3024897455
- 3008058446
- 3005632797
- 3011050560
- 3003851058
- 3010419931
- 3021595900
- 3010605427
- 3015997711
- 9611959
- 3010201834
- 3011238790
- 3042956952
- 3026363353
- 3007478974
- 3010621964
- 9615978
- 3008700497
- 9615905
- 3014269027
- 3010830834
- 3015058854
- 2648727
- 3001124136
- 3005024094
- 3009538921
- 1219821
- 3004168786
- 3014579161
- 3021827562
- 3021641087
- 3038187456
- 3042365317
- 8041003
- 8040614
- 9617444
- 1000266564
- 2939821
- 3013298431
- 3008298053
- 3010273867
- 3027977504
- 3013681444
- 3014847584
- 3024999439
- 3003823770
- 3003120666
- 3012034017
Source Documents#
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 |
| K220491 | Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs | Hainan Asther Medical Equipment Co., Ltd. | 2022-05-14 |
| 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 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases