510(k) K213325
- Device
- Disposable Medical Nitrile Examination Gloves- Tested For Use With Chemotherapy Drugs
- Applicant
- Anhui Xinyisheng Medical Technology Co., Ltd
- 510(k) number
- K213325
- Product code
- LZC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-01-28
- Date received
- 2021-10-05
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Wei Wei Tang
- Address
- #999 N. Of The Intersection Of Tonghe Rd. And G343 Rd. Suzhou CN 234300 234300
FDA Registration Numbers#
- 3009229300
- 8041150
- 3004995451
- 3005099803
- 3012341425
- 3004168786
- 3008298053
- 3014312726
- 3010621964
- 3031181949
- 3038284237
- 3017616393
- 1000254914
- 3036774599
- 3003851058
- 3004513970
- 3012304897
- 8040614
- 3038356900
- 3002661124
- 3005022483
- 8041180
- 3004553390
- 1058397
- 3012034017
- 3015422337
- 3022407383
- 3014819517
- 3021233711
- 3023272672
- 3010864832
- 3013514660
- 2028805
- 3011862887
- 3010273867
- 3021015522
- 3005568780
- 3015997711
- 8043736
- 3016785267
- 3017171460
- 3020521811
- 3022543478
- 3015412466
- 8041005
- 3013516822
- 1043549
- 3015142965
- 3038718579
- 3010220595
- 8041108
- 3010419931
- 3018167658
- 3027977504
- 9617444
- 3001124136
- 3012441043
- 3006796582
- 3016866909
- 3014421917
- 3030671502
- 3011089435
- 3015219124
- 3009496643
- 1000121056
- 3005632797
- 3016844398
- 3010194621
- 3026363353
- 3044819802
- 3044026004
- 2939821
- 9680466
- 3004681601
- 3007289408
- 3031180726
- 3005024009
- 3030447506
- 3014384460
- 9614502
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 |
| 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 |
| 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 |
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