The following data is part of a premarket notification filed by Glovco (m) Sdn. Bhd. with the FDA for Powdered Latex Examination Gloves With Protein Content Labeling Claim (100 Micrograms Or Less).
| Device ID | K994013 |
| 510k Number | K994013 |
| Device Name: | POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) |
| Classification | Latex Patient Examination Glove |
| Applicant | GLOVCO (M) SDN. BHD. LOT 760,(BLOCK A),JALAN HAJI SIRAT,OFF JALAN MERU Klang, Selangor D.e., MY 42100 |
| Contact | Tan Chwee Hock |
| Correspondent | Tan Chwee Hock GLOVCO (M) SDN. BHD. LOT 760,(BLOCK A),JALAN HAJI SIRAT,OFF JALAN MERU Klang, Selangor D.e., 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 | 1999-11-26 |
| Decision Date | 2000-01-20 |