Cap, Surgical
General, Plastic Surgery · 21 CFR 878.4040
Recent MDR events
26 adverse event reports on file
- HALYARD SURGICAL CAP BLUE UNIVERSAL SIZEFeb 2, 2026MalfunctionO&m Halyard, Inc.3014421917-2026-00002
- BOUFFANT CAP, ANNIE BLUE LARGEDec 17, 2021MalfunctionMolnlycke Health Care3004763499-2021-00002
- BLUE COMFORT BOUFFANT 24 INOct 18, 2018InjuryHubei Safeway Protective Products1423537-2018-00243
- SURGEONS HOOD TUCK BLUEAug 12, 2018MalfunctionMolnlycke Healthcare3004763499-2018-00002
- HOOD, SPP, WHITE, XLFeb 1, 2018InjuryMedline Industries Inc.1417592-2018-00007
- BOUFFANT CAPMar 29, 2016InjuryMedline Industries, Inc.1417592-2016-00025
- NON STERILE SURGEON CAPJan 15, 2016MalfunctionMedlineMW5059482
- BLUE COMFORT BOUFFANT 24 INOct 23, 2015MalfunctionCardinal Health Singapore 225 Pte Ltd1423537-2015-00069
- BOUFFANT CAPS PRO SERIESSep 4, 2015MalfunctionMedline Industries5055972
- BLUE COMFORT BOUFFANT 24 INJul 29, 2015MalfunctionCardinal Health1423537-2015-00055
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
296 firms currently registered for this product code
Medline Industries, Lp - Northfield
Northfield, IL, US
Zhangjiagang Bitoor Co., Ltd
ZHANGJIAGANG Jiangsu, CN
China (shenyang) Med-land Imp/exp Corp., Ltd.
Shanghai, CN
Xiantao Dingcheng Nonwoven Products Co., Ltd.
Xiantao Hubei, CN
Anqing Clean Dental Instrument Technology Co.,ltd
Anqing City Anhui, CN
Mega Plasticos Sa
Minga Guazu Alto Parana, PY
Nam Duong Personal Protective Equipment Manufacturing Joint Stock Company
Duy Tien Township Ha Nam, VN
Copioumed International, Inc.
TAIPEI Taiwan, CN
Suzhou Hengxiang Imp. & Exp. Co., Ltd
SUZHOU Jiangsu, CN
Wuhan Zonsen Medical Products Co., Ltd
Wuhan Hubei, CN
Picard Healthcare Technology (dongguan) Co. Ltd
Dongguan Guangdong, CN
Anhui Jm Healthcare Products Co.,ltd.
Shouxian Anhui, CN
Wear Tex S. De R.l. De C.v.
Torreon Coahuila, MX
Toc Logistics / Sol-millenium Canada, Inc.
Balzac Alberta, CA
Grupo Alyger, S.a. De C.v.
Guadalupe Nuevo Leon, MX
Shanghai Dochem Industries Co., Ltd.
SHANGHAI, CN
Texbond Nonwovens
Pondicherry Puducherry, IN
Jiujiang Huada Medical Dressing Co., Ltd.
JIUJIANG Jiangxi, CN
Gd Group Usa Company
Bartlett, IL, US
Guangzhou Baoli Hardware & Electronic Co.,ltd.
Guangzhou Guangdong, CN
Changzhou 3r Medical Device Technology Co., Ltd.
Changzhou Jiangsu, CN
Zhejiang Mediunion Healthcare Group Co.,ltd
Ningbo Zhejiang, CN
Hubei Deming Healthcare Products Co.,ltd.first Branch
Xiantao City Hubei, CN
Fujian Dashan Paper Co Ltd
QUANZHOU Fujian, CN
Battech
Irvine, CA, US
510(k) clearances
32 clearances for this product code
- American Seal Co.Sep 9, 1997
K972227 · SHOE COVER
- Amerasia Corp.Mar 15, 1996
K955833 · NIOMED SURGICAL CAPS
- Thai Disposable Products Co., Ltd.Mar 12, 1996
K954556 · SURGICAL CAP
- Amerasia Corp.Jan 23, 1996
K954454 · NIOMED SURGICAL HOOD
- Amerasia Corp.Jan 23, 1996
K954455 · NIOMED BOUFFANT CAPS
- American Threshold Industries, Inc.Jan 5, 1996
K953879 · SURGEON'S CAP
- American Threshold Industries, Inc.Jan 5, 1996
K953878 · BOUFFANT CAP
- Gem Nonwovews, Inc.Oct 4, 1991
K913700 · DISPOSABLE BOUFFANT CAP