510(k) K032374
- Device
- POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED
- Applicant
- PERUSAHAAN GETAH ASAS SDN BHD
- 510(k) number
- K032374
- Product code
- LZC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-10-22
- Date received
- 2003-08-01
- 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
- JAMES F LOGAN
- Address
- 1301 Defense Hwy. Gambrills MD US 21054 21054
FDA Registration Numbers#
- 1119294
- 3008076203
- 3019849096
- 3025231442
- 3013037032
- 3009503464
- 3017171460
- 3015128453
- 3030447506
- 3005568780
- 3021841055
- 2024980
- 3005595283
- 9615914
- 9614175
- 3016785267
- 3005024094
- 3018507299
- 3019585047
- 8041180
- 3004681601
- 3010363542
- 3005034064
- 3005632797
- 9616501
- 3030582179
- 3004553390
- 3016601021
- 3014819517
- 3015727296
- 3001970230
- 8043848
- 3013516822
- 3022953895
- 3018108902
- 8041150
- 3011209798
- 2086655
- 3015173212
- 3011391433
- 9615978
- 3024897455
- 3019798835
- 1000121056
- 3013034812
- 3007327603
- 3021206557
- 2030624
- 3013565389
- 3012441043
- 8040614
- 3014384460
- 3010763223
- 3011862887
- 3021595900
- 3016844398
- 3014345238
- 3010220595
- 3001124136
- 3026363353
- 3013546437
- 3004704697
- 3003699698
- 1054241
- 8041003
- 3021591322
- 3024999439
- 2437780
- 3009118264
- 2124215
- 1043549
- 3015422337
- 3021827562
- 3038276731
- 3015335977
- 2028805
- 3011649314
- 3003120666
- 2032521
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 |
| 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