The following data is part of a premarket notification filed by Seal Polymer Industries Bhd. with the FDA for Non-sterile Powder-free Latex Examination Gloves With A Protein Labeling Claim (50 Micrograms Or Less Total Water Extrac.
| Device ID | K991849 |
| 510k Number | K991849 |
| Device Name: | NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL WATER EXTRAC |
| Classification | Latex Patient Examination Glove |
| Applicant | SEAL POLYMER INDUSTRIES BHD. LT 72706, JALAN LAHAT, KAWASAN PERINDUSTRIAN BUKIT MERAH Lahat, Ipoh, Perak, MY 31500 |
| Contact | Chan Chin Hong |
| Correspondent | Chan Chin Hong SEAL POLYMER INDUSTRIES BHD. LT 72706, JALAN LAHAT, KAWASAN PERINDUSTRIAN BUKIT MERAH Lahat, Ipoh, Perak, MY 31500 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-01 |
| Decision Date | 1999-07-07 |