The following data is part of a premarket notification filed by Koon Seng Sdn.bhd with the FDA for Ks-care Powder Free Polymer Coated Latex Examination Glove With Protein Content Labeling Claim (50ug Or Less).
| Device ID | K093375 |
| 510k Number | K093375 |
| Device Name: | KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50UG OR LESS) |
| Classification | Latex Patient Examination Glove |
| Applicant | KOON SENG SDN.BHD 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Jigar Shah |
| Correspondent | Jay Y Kogoma INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-10-29 |
| Decision Date | 2009-12-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50096295133368 | K093375 | 000 |
| 50885380134768 | K093375 | 000 |
| 50885380134782 | K093375 | 000 |
| 50885380134799 | K093375 | 000 |
| 50885380134805 | K093375 | 000 |
| 50885380134812 | K093375 | 000 |
| 50096295133337 | K093375 | 000 |
| 50096295133344 | K093375 | 000 |
| 50096295133351 | K093375 | 000 |
| 10843079100076 | K093375 | 000 |