510(k) K212639
- Device
- Disposable Medical Nitrile Examination Gloves (Non Sterile)
- Applicant
- Jiangsu Nanfang Medical Co., Ltd
- 510(k) number
- K212639
- Product code
- LZC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-12-08
- Date received
- 2021-08-20
- Regulation
- 880.6250
- Classification name
- Patient Examination Glove, Specialty
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Xia Li
- Address
- # 1 Guoxiang Rd., Wujin Economic Development Zone, Wujin Changzhou CN 213149 213149
FDA Registration Numbers#
- 3003699698
- 3007407626
- 3014269027
- 3015335977
- 3006796582
- 3012341425
- 1319302
- 2032521
- 3034618336
- 3010605427
- 3033715710
- 3005012805
- 3011238790
- 9613997
- 3026363353
- 3021286079
- 3026062711
- 1054241
- 3044819802
- 3016785267
- 8041120
- 3031181949
- 9681260
- 3031180726
- 3025231442
- 3027601983
- 3014312726
- 3007842585
- 3014847584
- 3016685880
- 3011862887
- 3019798835
- 9615914
- 9614175
- 3015173212
- 3012441043
- 3004681601
- 3012429634
- 3015058854
- 3021841055
- 8041180
- 3008058446
- 3004513970
- 3015128453
- 3015142965
- 3030187570
- 3038284237
- 3003823770
- 3019769825
- 3005060582
- 3044026004
- 3010864832
- 3009503464
- 2183301
- 8043736
- 3009496643
- 3005034064
- 9616088
- 3021233711
- 3016413634
- 3021591322
- 3038718579
- 3015727296
- 3028162329
- 3003851058
- 3025606191
- 3016601021
- 3014345238
- 3010273867
- 3015335034
- 3024706752
- 3010419931
- 3013514660
- 3013451367
- 3009055041
- 3007502227
- 3013037032
- 3014164734
- 1649518
- 3009538921
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 |
| 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 |
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