The following data is part of a premarket notification filed by Professional Latex Sdn Bhd with the FDA for Powder Free Nitrile Examination Glove.
| Device ID | K171667 |
| 510k Number | K171667 |
| Device Name: | Powder Free Nitrile Examination Glove |
| Classification | Polymer Patient Examination Glove |
| Applicant | Professional Latex Sdn Bhd Lot 52, Jalan Logam 2, Kamunting Raya Lndustrial Kamunting, MY 34600 |
| Contact | Yoon Lim Kok |
| Correspondent | Terence Lim Professional Latex Sdn Bhd Lot 52, Jalan Logam 2, Kamunting Raya Lndustrial Kamunting, MY 34600 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-05 |
| Decision Date | 2017-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20817508022397 | K171667 | 000 |
| 20817508022373 | K171667 | 000 |
| 20817508022366 | K171667 | 000 |
| 20817508022342 | K171667 | 000 |
| 20817508022335 | K171667 | 000 |