510(k) K032444
- Device
- NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPY
- Applicant
- Cardinal Health
- 510(k) number
- K032444
- Product code
- LZC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-11-13
- Date received
- 2003-08-08
- 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
- ERICA SETHI
- Address
- 1500 Waukegan Rd. Bldg. Wm Mcgaw Park IL US 60085 60085
FDA Registration Numbers#
- 3012748721
- 3013557562
- 3026363353
- 3044819802
- 3036774599
- 9610406
- 3015142965
- 2437780
- 3011238790
- 3013681444
- 3004122598
- 3019769825
- 3015384427
- 2086655
- 1828132
- 3014164734
- 3013565389
- 2028805
- 1000121056
- 9613998
- 3014819517
- 3003744503
- 9681163
- 3027977504
- 3011391433
- 1833700
- 9617444
- 3001970230
- 1054241
- 3021206556
- 3003823770
- 3024755882
- 3006534695
- 3013298431
- 3014312726
- 3021233711
- 3021595900
- 8043848
- 3024897455
- 3008058446
- 1058397
- 3042956952
- 3021591322
- 3011862887
- 3038185756
- 1030451
- 3003199637
- 3017114229
- 3006552561
- 9710583
- 3034618336
- 3010363542
- 3027601983
- 3005024094
- 3018779144
- 3010602489
- 9616088
- 3009503464
- 3001124136
- 1417592
- 3016413634
- 3012341425
- 3005060582
- 3010582952
- 3016844398
- 3016609999
- 3019252794
- 3012034017
- 8041005
- 3034605486
- 3009496643
- 3038284237
- 3010419931
- 3004681601
- 3025231442
- 3044026004
- 3011200663
- 3015128453
- 3019798835
- 3003699698
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#
summary
FDA Review#
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