The following data is part of a premarket notification filed by Matang Mfg. Sdn. Bhd. with the FDA for Matang Powdered Latex Patient Examination Glove With Protein Labeling Claim (50 Microgram Or Less.
| Device ID | K000985 |
| 510k Number | K000985 |
| Device Name: | MATANG POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS |
| Classification | Latex Patient Examination Glove |
| Applicant | MATANG MFG. SDN. BHD. 6324 MEETING HOUSE WAY Alexandria, VA 22312 -1718 |
| Contact | Kok-kee Hon |
| Correspondent | Kok-kee Hon MATANG MFG. SDN. BHD. 6324 MEETING HOUSE WAY Alexandria, VA 22312 -1718 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-27 |
| Decision Date | 2000-04-24 |