510(k) K895781
- Device
- ANSELL E.P. EXTRA-PROTECTION EXAMINATION GLOVES
- Applicant
- ANSELL INTL.
- 510(k) number
- K895781
- Product code
- LZC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-03-09
- Date received
- 1989-09-27
- Regulation
- 880.6250
- Classification name
- Patient Examination Glove, Specialty
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAUL CACIOLI
- Address
- Lot 80, Air Keroh Ind. Est. Melaka MT 75150 75150
FDA Registration Numbers#
- 3030671502
- 3025303965
- 3017610877
- 3009503464
- 3042956952
- 1828132
- 3042940407
- 1000254914
- 3011689956
- 3008221237
- 3028652705
- 3022543478
- 3031181949
- 2028805
- 3015128453
- 3012304897
- 3001124136
- 3012429634
- 3009243435
- 3038185756
- 3002806603
- 3013034812
- 9615914
- 3016785252
- 3027977504
- 3021641087
- 3004681601
- 3002807090
- 3021206556
- 3011189071
- 3003199637
- 3043739177
- 3007502227
- 3010602489
- 3012748721
- 3020984755
- 3014269027
- 8040614
- 3009055041
- 3024706752
- 3020521811
- 3019769825
- 1058397
- 3013298431
- 3014819517
- 3038284237
- 3011238790
- 3026263452
- 3006534695
- 8041180
- 1043549
- 3005632797
- 3014384460
- 3015384427
- 3018108902
- 3007289408
- 9680466
- 8041005
- 3014345238
- 3007327603
- 3018167658
- 3019798835
- 3017171460
- 3001970230
- 3015335977
- 3010194621
- 3011211126
- 3010864832
- 3009229300
- 1219821
- 3014847584
- 3026062711
- 8043848
- 9614502
- 3014164734
- 3016785267
- 3021591322
- 9680622
- 9611959
- 3015142965
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