The following data is part of a premarket notification filed by Flexitech Sdn. Bhd. with the FDA for Powder Free Latex Examination Gloves, W/ Protein Labeling Claim.
| Device ID | K990501 |
| 510k Number | K990501 |
| Device Name: | POWDER FREE LATEX EXAMINATION GLOVES, W/ PROTEIN LABELING CLAIM |
| Classification | Latex Patient Examination Glove |
| Applicant | FLEXITECH SDN. BHD. LOT 5071, BATU 5 1/2, JALAN MERU Klang, Selangor, MY 41050 |
| Contact | Tu Ah Kim |
| Correspondent | Tu Ah Kim 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 | 1999-02-17 |
| Decision Date | 1999-04-02 |