510(k) K221164
- Device
- Powder Free Nitrile Examination Glove - Blue, Non-Sterile, Tested for use with Chemotherapy Drugs and Fentanyl
- Applicant
- Hong Seng Gloves Sdn Bhd
- 510(k) number
- K221164
- Product code
- LZA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-08-30
- Date received
- 2022-04-22
- Regulation
- 880.6250
- Classification name
- Polymer Patient Examination Glove
- 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
- Zahari Bin Darus
- Address
- Lot 97, Jalan 10, Kawasan Perusahaan Bakar Arang Sungai Petani MY 08000 08000
FDA Registration Numbers#
- 3015142965
- 3042956952
- 3014384460
- 8041108
- 3013428737
- 1319302
- 3045079147
- 9615978
- 3008604557
- 3030682048
- 3030214028
- 3005460813
- 3010402691
- 3007502227
- 3008489813
- 9680794
- 8040880
- 3014743234
- 3017114229
- 3010195579
- 3014268334
- 3030671502
- 9681660
- 3009218271
- 3009963993
- 1250045
- 3013451367
- 3010363542
- 3016413634
- 3015219124
- 3024999439
- 3015128453
- 3005060582
- 2083656
- 9617453
- 3023862
- 3013514660
- 3005024094
- 3012421607
- 8040614
- 3010436932
- 1423537
- 3011658061
- 3036774599
- 3007842585
- 3015477649
- 3010148335
- 3038277359
- 2434008
- 3034618336
- 3021206557
- 3004939660
- 9613997
- 3010621964
- 3014269027
- 1649518
- 3011191255
- 3014593437
- 1928237
- 3019849096
- 3021286079
- 3010600155
- 3009474977
- 3006157842
- 3007327603
- 3005621729
- 2939821
- 9710583
- 3009429841
- 3011200663
- 3030419987
- 3017616393
- 3015335977
- 9614175
- 3038284237
- 3009784353
- 3024374107
- 3025231442
- 3014421917
- 3009176340
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LZA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262208 | Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid;Non-sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid – Blue;Non-sterile, Powder Free Nitrile Examination Gloves - Pink | Yty Industry (Manjung) Sdn Bhd | 2026-10-01 |
| K261793 | Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color) | Maxter Healthcare, Inc. | 2026-09-09 |
| K262542 | Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance Claim | Top Glove Sdn. Bhd. | 2026-09-09 |
| K260312 | Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid | Gmp Medicare Sdn. Bhd. | 2026-09-08 |
| K261749 | Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Cardinalhealth | 2026-09-02 |
| K260794 | NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLOR | Kossan International Sdn Bhd | 2026-08-18 |
| K262014 | PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves | O&M Halyard, Inc. | 2026-07-21 |
| K254285 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Violet Blue | Hartalega NGC Sdn. Bhd. | 2026-07-20 |
| K252117 | Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution | Sw Technologies, Inc. | 2026-06-24 |
| K253824 | Powder Free Nitrile Examination Gloves Non-Sterile Black | Kanglongda Vietnam Protection Technology Company Limited | 2026-06-18 |
| K260867 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black) | Hartalega NGC Sdn. Bhd. | 2026-06-17 |
| K260703 | Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl | S&S Glove Corporation | 2026-06-03 |
| K260806 | Nitrile Disposable Examination Gloves | Vista Industries,, LLC | 2026-06-03 |
| K253160 | Syntex Exam Gloves | Basic Medical Technology, Inc. | 2026-01-23 |
| K252549 | Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid | Kossan International Sdn Bhd | 2026-01-13 |