The following data is part of a premarket notification filed by Concept Rubber Products Sdn Bhd with the FDA for Almatex Powder-free Latex Exanination Gloves With Protien Labeling Claim 50 Micrograms Or Less.
| Device ID | K003213 |
| 510k Number | K003213 |
| Device Name: | ALMATEX POWDER-FREE LATEX EXANINATION GLOVES WITH PROTIEN LABELING CLAIM 50 MICROGRAMS OR LESS |
| Classification | Latex Patient Examination Glove |
| Applicant | CONCEPT RUBBER PRODUCTS SDN BHD 2050 JALAN ALMA BUKIT MERTAJAM, Seberang Perai, Penang, MY 14000 |
| Contact | Teoh Hun Lim |
| Correspondent | Teoh Hun Lim CONCEPT RUBBER PRODUCTS SDN BHD 2050 JALAN ALMA BUKIT MERTAJAM, Seberang Perai, Penang, MY 14000 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-13 |
| Decision Date | 2000-11-29 |