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#
- 3018507299
- 1119294
- 3010864832
- 1417592
- 3005024009
- 3015335977
- 3014683120
- 3019798835
- 3015219124
- 3014312726
- 3010220595
- 1000121056
- 3016844398
- 3025231442
- 3005024094
- 3026263452
- 3021206557
- 3013034812
- 3008604557
- 9614175
- 3038718579
- 3004553390
- 3004122598
- 3004513970
- 2024980
- 3019849096
- 3013516822
- 9615914
- 3011238790
- 3028652705
- 3014164734
- 1643817
- 3024897455
- 3011287770
- 1058397
- 3024706752
- 3007407626
- 3038284237
- 3022543478
- 3012429634
- 3005012805
- 3014384460
- 3011191255
- 3012034017
- 8041003
- 3003744503
- 3007289408
- 3005034064
- 2028805
- 3009118264
- 3019840054
- 3004577220
- 3004681601
- 3015422337
- 3005022483
- 9615905
- 3005632797
- 3021841055
- 3036774599
- 3009055041
- 3013565389
- 9680466
- 3043739177
- 3015384427
- 3015727296
- 1319302
- 1219821
- 3009538921
- 3021591322
- 3034605486
- 3008221237
- 3011200663
- 3006796582
- 3019252794
- 9616088
- 3012748721
- 3020984755
- 8043736
- 3003699698
- 2124215
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