The following data is part of a premarket notification filed by Smart Glove Corp. Sdn Bhd with the FDA for Powder Free Nitrile Examination Glove (blue).
| Device ID | K091147 |
| 510k Number | K091147 |
| Device Name: | POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) |
| Classification | Polymer Patient Examination Glove |
| Applicant | SMART GLOVE CORP. SDN BHD BATU 5 3/4, JALAN KAPAR KLANG Selangor Darul Eshan, MY 42100 |
| Contact | Foo Khon Pu |
| Correspondent | Foo Khon Pu SMART GLOVE CORP. SDN BHD BATU 5 3/4, JALAN KAPAR KLANG Selangor Darul Eshan, MY 42100 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-20 |
| Decision Date | 2009-07-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850018123812 | K091147 | 000 |
| 10850018123799 | K091147 | 000 |
| 10850018123775 | K091147 | 000 |
| 10850018123751 | K091147 | 000 |
| 10850018123737 | K091147 | 000 |
| 10850018123713 | K091147 | 000 |
| 10850018123690 | K091147 | 000 |