The following data is part of a premarket notification filed by Seal Polymer Industries Bhd. with the FDA for Cashmere Polymer Coated Powder Free Nitrile Examination Gloves.
| Device ID | K042238 |
| 510k Number | K042238 |
| Device Name: | CASHMERE POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | SEAL POLYMER INDUSTRIES BHD. LOT 72706,JALAN LAHAT, KAWASAN PERINDUSTRIAN BUKIT MERAH Lahat, Ipoh, Perak, MY 31500 |
| Contact | Chun Chooi Fong |
| Correspondent | Chun Chooi Fong SEAL POLYMER INDUSTRIES BHD. LOT 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 | 2004-08-18 |
| Decision Date | 2004-09-16 |
| Summary: | summary |