The following data is part of a premarket notification filed by Seal Polymer Industries Bhd. with the FDA for Cashmere Non-sterile Blue Powdered Nitrile Examination Glovesblue And Green).
| Device ID | K993134 |
| 510k Number | K993134 |
| Device Name: | CASHMERE NON-STERILE BLUE POWDERED NITRILE EXAMINATION GLOVESBLUE AND GREEN) |
| Classification | Polymer 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 | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-20 |
| Decision Date | 1999-11-17 |
| Summary: | summary |