The following data is part of a premarket notification filed by Quality Gallant Sdn. Bhd. with the FDA for Powder Free Nitrile (dark Blue) Examination Gloves.
| Device ID | K092874 |
| 510k Number | K092874 |
| Device Name: | POWDER FREE NITRILE (DARK BLUE) EXAMINATION GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | QUALITY GALLANT SDN. BHD. LOT 1874, JALAN KAMPUNG DEW SIMPANG HALT, SIMPANG Taiping, Perak, MY 34700 |
| Contact | Terence Read |
| Correspondent | Terence Read QUALITY GALLANT SDN. BHD. LOT 1874, JALAN KAMPUNG DEW SIMPANG HALT, SIMPANG Taiping, Perak, MY 34700 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-18 |
| Decision Date | 2010-06-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850001981453 | K092874 | 000 |
| 00850001981422 | K092874 | 000 |
| 00850001981392 | K092874 | 000 |
| 00850001981361 | K092874 | 000 |
| 00810052977539 | K092874 | 000 |
| 00810052977249 | K092874 | 000 |