The following data is part of a premarket notification filed by Smart Glove Corp. Sdn Bhd with the FDA for Polymer Coat, Powder Free, Latex Examination Gloves With Protein Content Labeling Claim (50 Micrograms Or Less).
| Device ID | K002568 |
| 510k Number | K002568 |
| Device Name: | POLYMER COAT, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
| Classification | Latex Patient Examination Glove |
| Applicant | SMART GLOVE CORP. SDN BHD LOT 6487 BATU 5 3/4 JALAN KAPAR Klang Selangor, MY 42100 |
| Contact | Foo K Pu |
| Correspondent | Foo K Pu SMART GLOVE CORP. SDN BHD LOT 6487 BATU 5 3/4 JALAN KAPAR Klang Selangor, 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 | 2000-08-18 |
| Decision Date | 2000-10-03 |