The following data is part of a premarket notification filed by Seal Polymer Industries Bhd. with the FDA for Cashmere Non-sterile Powdered Nitrile Examination Gloves Blue And Green.
Device ID | K993133 |
510k Number | K993133 |
Device Name: | CASHMERE NON-STERILE POWDERED NITRILE EXAMINATION GLOVES BLUE AND GREEN |
Classification | Polymer Patient Examination Glove |
Applicant | SEAL POLYMER INDUSTRIES BHD. LT 72706 KAWASAN PERINDUSTRIAN BUKIT MERAH Lahat, Perak, MY 31500 |
Contact | Chan Chin Hong |
Correspondent | Chan Chin Hong SEAL POLYMER INDUSTRIES BHD. LT 72706 KAWASAN PERINDUSTRIAN BUKIT MERAH Lahat, 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 |