The following data is part of a premarket notification filed by Yty Industry (manjung) Sdn. Bhd. with the FDA for Non-sterile, Powder Free, Polymer Coated Latex Examination Gloves With Water Extractable Protein Claim Of 50 Microgram O.
| Device ID | K991742 |
| 510k Number | K991742 |
| Device Name: | NON-STERILE, POWDER FREE, POLYMER COATED LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN CLAIM OF 50 MICROGRAM O |
| Classification | Latex Patient Examination Glove |
| Applicant | YTY INDUSTRY (MANJUNG) SDN. BHD. PO BOX 4341 Crofton, MD 21114 |
| Contact | E. J. Smith |
| Correspondent | E. J. Smith YTY INDUSTRY (MANJUNG) SDN. BHD. PO BOX 4341 Crofton, MD 21114 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-21 |
| Decision Date | 1999-06-21 |
| Summary: | summary |