510(k) K172864
- Device
- Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs
- Applicant
- Maxter Glove Manufacturing Sdn Bhd
- 510(k) number
- K172864
- Product code
- LZC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-05-02
- Date received
- 2017-09-20
- 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
- Yap Peak Geeh
- Address
- Lot 6070, Jalan Haji Abdul Manah 6th Miles Off Jalan Meru Klang MY 41050 41050
FDA Registration Numbers#
- 3009118264
- 3011649314
- 3013557562
- 3025231442
- 3038356900
- 3042956952
- 3007791481
- 3008700497
- 3015142965
- 3022953895
- 3016844398
- 3007502227
- 3013451367
- 3005022483
- 3009538921
- 3008509176
- 3021595900
- 3030682048
- 3015173212
- 3010582952
- 3006552561
- 3028162329
- 1643817
- 3005060582
- 3007478974
- 3010201834
- 3015335034
- 1417592
- 3010605427
- 3005024009
- 3031180726
- 1055236
- 2028805
- 3008298053
- 3003851058
- 3006979699
- 1423537
- 3008221237
- 3011050560
- 3010436932
- 3038187455
- 3012341425
- 3006534695
- 3022543478
- 3013576504
- 3004513970
- 3015128453
- 3005099803
- 3018779144
- 1058397
- 3038187456
- 9611959
- 2032521
- 3021641087
- 3015219124
- 2183301
- 3003199637
- 3030187570
- 3010419931
- 9610406
- 2939821
- 8041150
- 8043848
- 3004681601
- 3010621964
- 3010830834
- 8041120
- 3019585047
- 2437780
- 3044819802
- 3014683120
- 3007407626
- 3007327603
- 1000266564
- 9613997
- 3009503464
- 3017616393
- 3019840054
- 3010864832
- 3004553390
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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