The following data is part of a premarket notification filed by Flexitech Sdn. Bhd. with the FDA for Polymer Coated, Powder Free, Latex Examination Gloves With Protein Content Labeling Claim (50 Micrograms Or Less).
| Device ID | K994354 |
| 510k Number | K994354 |
| Device Name: | POLYMER COATED, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
| Classification | Latex Patient Examination Glove |
| Applicant | FLEXITECH SDN. BHD. LOT 5071, BATU 5 1/2, JALAN MERU Klang, Selangor, MY 41050 |
| Contact | Y. F Hew |
| Correspondent | Y. F Hew FLEXITECH SDN. BHD. LOT 5071, BATU 5 1/2, JALAN MERU Klang, Selangor, MY 41050 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-23 |
| Decision Date | 2000-01-31 |