510(k) K062778
- Device
- STERILE POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED
- Applicant
- Wear Safe Malaysia Sdn. Bhd.
- 510(k) number
- K062778
- Product code
- LZA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-10-27
- Date received
- 2006-09-18
- 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
- N
Applicant Contact#
- Contact
- LIM L BUNG
- Address
- Lot 1, Leboh Hishamuddin Satu, North Klang Straits Ind. Area Port Klang, Selangor, D.E. MY 42000 42000
FDA Registration Numbers#
- 9680794
- 3025303965
- 3008384335
- 3042956952
- 3013496867
- 1000254914
- 3011689956
- 3015128453
- 3012304897
- 3001124136
- 3038185756
- 3013034812
- 3021641087
- 3011189071
- 3043739177
- 3043226252
- 3020984755
- 2434008
- 3020521811
- 2435946
- 1220477
- 1058397
- 3017207705
- 3038284237
- 3013998568
- 3011238790
- 3004111573
- 3006534695
- 3010934635
- 3018108902
- 3017940518
- 3004704697
- 3014345238
- 3010194621
- 3033527714
- 3014847584
- 8043848
- 3009784353
- 1222115
- 3012441043
- 3038187455
- 3033715710
- 3008298053
- 3045062172
- 3004513970
- 3042765418
- 3030455652
- 3011050560
- 3038276166
- 2939821
- 3013557562
- 3005621729
- 3014449454
- 3024897455
- 3014312726
- 3030419987
- 3015422337
- 3030682048
- 3013037032
- 3008700497
- 1928237
- 3022953895
- 3015173212
- 3008253024
- 3038356900
- 3021015522
- 3007392007
- 3015140351
- 3010195579
- 3014593437
- 2954902
- 1038758
- 3007791481
- 3038718579
- 2431014
- 3021394840
- 9615978
- 3005322833
- 3007220726
- 3011287770
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LZA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
| K251141 | Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Mercator Medical (Thailand), Ltd. | 2025-11-17 |
| K250861 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black) | Hartalega NGC Sdn. Bhd. | 2025-10-23 |