510(k) K121811
- Device
- POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES
- Applicant
- SHEN WEI (USA), INC.
- 510(k) number
- K121811
- Product code
- LZC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-11-21
- Date received
- 2012-06-20
- Regulation
- 880.6250
- Classification name
- Patient Examination Glove, Specialty
- Medical specialty
- General Hospital
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ALBERT LI
- Address
- 33278 Central Ave. Suite 102 Union City CA US 94587 94587
FDA Registration Numbers#
- 3028652705
- 3015128453
- 3016413634
- 3005024009
- 9710583
- 2086655
- 3006796582
- 2939935
- 3011649314
- 3010220595
- 3012421607
- 3021591319
- 2437780
- 9613998
- 3016866909
- 3021595900
- 3016844398
- 3019798835
- 3011287770
- 3004168786
- 2183301
- 3004513970
- 3024999439
- 3044026004
- 1119294
- 1000266564
- 3004995451
- 3010436932
- 3012748721
- 3025231442
- 3020984755
- 3031180726
- 3021206557
- 8041108
- 3011189071
- 3015335034
- 9617444
- 3005099803
- 3038592309
- 9616088
- 3008700497
- 3014683120
- 3003199637
- 3012304897
- 3019769825
- 3018108902
- 2028805
- 3042365317
- 3011689956
- 3015219124
- 3030470903
- 3011862887
- 3027601983
- 1043214
- 3034618336
- 8043848
- 3021286079
- 3008298053
- 3005060582
- 1063851
- 3004553390
- 3009243435
- 3013451367
- 3038187456
- 3009055041
- 3011050560
- 3013576504
- 3017610877
- 3018507299
- 3013428737
- 3018779144
- 3021206556
- 9610406
- 3005632797
- 3014579161
- 8041150
- 3021015522
- 3014819517
- 3010621964
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 |
| 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 |
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