The following data is part of a premarket notification filed by Smart Glove Corp. Sdn Bhd with the FDA for Latex Examination Glove Powder Free.
| Device ID | K974870 |
| 510k Number | K974870 |
| Device Name: | LATEX EXAMINATION GLOVE POWDER FREE |
| Classification | Latex Patient Examination Glove |
| Applicant | SMART GLOVE CORP. SDN BHD LOT 6487 BATU 5 3/4 SEMENTA, JALAN KAPAR Selangor Darul Ehsan, MY 42100 |
| Contact | Foo Khon Pu |
| Correspondent | Foo Khon Pu SMART GLOVE CORP. SDN BHD LOT 6487 BATU 5 3/4 SEMENTA, JALAN KAPAR Selangor Darul Ehsan, MY 42100 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-29 |
| Decision Date | 1998-03-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 19551005270250 | K974870 | 000 |
| 19551005270243 | K974870 | 000 |
| 19551005270236 | K974870 | 000 |
| 19551005270229 | K974870 | 000 |
| 19551005270212 | K974870 | 000 |
| 19551005270205 | K974870 | 000 |
| 19551005270199 | K974870 | 000 |