The following data is part of a premarket notification filed by Yty Industry (manjung) Sdn. Bhd. with the FDA for Evergreen Non-sterile, Powder-free, Protein Content Labeling Claim Examination Gloves: Natural, Blue & Pink.
| Device ID | K983608 |
| 510k Number | K983608 |
| Device Name: | EVERGREEN NON-STERILE, POWDER-FREE, PROTEIN CONTENT LABELING CLAIM EXAMINATION GLOVES: NATURAL, BLUE & PINK |
| 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 | 1998-10-14 |
| Decision Date | 1998-11-05 |
| Summary: | summary |