MULTISAFE POWDER-FREE PATIENT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

Latex Patient Examination Glove

MULTISAFE SDN BHD

The following data is part of a premarket notification filed by Multisafe Sdn Bhd with the FDA for Multisafe Powder-free Patient Latex Examination Gloves With Protein Content Labeling Claim (50 Micrograms Or Less).

Pre-market Notification Details

• Device ID: K000999
• 510k Number: K000999
• Device Name: MULTISAFE POWDER-FREE PATIENT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
• Classification: Latex Patient Examination Glove
• Applicant: MULTISAFE SDN BHD LOT 764 BIDOR INDUSTRIAL ESTATE 35500 Bidor, Perak, MY 35500
• Contact: Abd. Hadi Bin Husin
• Correspondent: Abd. Hadi Bin Husin; MULTISAFE SDN BHD LOT 764 BIDOR INDUSTRIAL ESTATE 35500 Bidor, Perak, MY 35500
• Product Code: LYY
• CFR Regulation Number: 880.6250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-03-28
• Decision Date: 2000-05-22

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00697383916655	K000999	000
D773410HTPFM1	K000999	000
D773410HTPFL1	K000999	000
D7664332082	K000999	000
D7664332072	K000999	000
D7664332062	K000999	000
D7664332052	K000999	000
20697383968658	K000999	000
10697383968651	K000999	000
20889813060074	K000999	000
20889813060067	K000999	000
20889813060050	K000999	000
D773410HTPFS1	K000999	000
D773410HTPFXL1	K000999	000
00697383916549	K000999	000
00697383916433	K000999	000
00697383916327	K000999	000
00697383916211	K000999	000
00697383916105	K000999	000
D773410PPFXS21	K000999	000
D773410PPFXL21	K000999	000
D773410PPFS21	K000999	000
D773410PPFM21	K000999	000
D773410PPFL21	K000999	000
D773410HTPFXS1	K000999	000
20889813060043	K000999	000