MEDLINE REUSABLE SURGICAL GOWNS (100X)

Gown, Surgical

MEDLINE INDUSTRIES, INC.

The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Reusable Surgical Gowns (100x).

Pre-market Notification Details

• Device ID: K031933
• 510k Number: K031933
• Device Name: MEDLINE REUSABLE SURGICAL GOWNS (100X)
• Classification: Gown, Surgical
• Applicant: MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060
• Contact: Stacey Bolen-wolverton
• Correspondent: Stacey Bolen-wolverton; MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060
• Product Code: FYA
• CFR Regulation Number: 878.4040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-06-23
• Decision Date: 2003-09-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00810019801976	K031933	000
00812564034755	K031933	000
00812564034762	K031933	000
00812564034779	K031933	000
00812564034823	K031933	000
00812564035011	K031933	000
00812564035714	K031933	000
00812564035738	K031933	000
00812564035745	K031933	000
00812564035752	K031933	000
00812564035769	K031933	000
00812564035776	K031933	000
00812564035783	K031933	000
00812564035790	K031933	000
00812564035936	K031933	000
00812564035943	K031933	000
00812564034748	K031933	000
00812564033628	K031933	000
00812564033314	K031933	000
00810019801891	K031933	000
00810019801198	K031933	000
00810019801204	K031933	000
00810019801211	K031933	000
00810019801242	K031933	000
00810019801259	K031933	000
00810019801266	K031933	000
00810019801273	K031933	000
00812564032805	K031933	000
00810019801112	K031933	000
00812564037145	K031933	000
00812564032270	K031933	000
00812564032881	K031933	000
00812564032980	K031933	000
00812564033291	K031933	000
00812564035950	K031933	000
00812564035967	K031933	000
00812564038944	K031933	000
00812564038982	K031933	000
00812564039026	K031933	000
00812564039033	K031933	000
00812564039040	K031933	000
00812564039057	K031933	000
00812564039064	K031933	000
00812564039071	K031933	000
00812564039088	K031933	000
00812564039095	K031933	000
00812564039439	K031933	000
00812564039736	K031933	000
00812564039743	K031933	000
00812564039750	K031933	000
00812564039767	K031933	000
00812564038920	K031933	000
00812564038586	K031933	000
00812564037923	K031933	000
00812564037190	K031933	000
00812564037206	K031933	000
00812564037213	K031933	000
00812564037343	K031933	000
00812564037381	K031933	000
00812564037466	K031933	000
00812564037473	K031933	000
00812564037596	K031933	000
00812564037626	K031933	000
00812564037633	K031933	000
00812564037640	K031933	000
00812564037688	K031933	000
00812564037701	K031933	000
00812564037718	K031933	000
00812564037725	K031933	000
00812564039774	K031933	000