Surgeon's Gloves
General, Plastic Surgery · 21 CFR 878.4460
A surgeon's glove is a disposable device made of natural rubber latex or synthetic polymers that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
Recent MDR events
770 adverse event reports on file
- SENSICAREJul 29, 2026MalfunctionMedline Industries, Lp1417592-2026-08002
- SENSICAREJul 28, 2026MalfunctionMedline Industries, Lp1417592-2026-07973
- SENSICAREJul 28, 2026MalfunctionMedline Industries, Lp1417592-2026-07939
- SENSICAREJul 28, 2026MalfunctionMedline Industries, Lp1417592-2026-07961
- SENSICAREJul 28, 2026MalfunctionMedline Industries, Lp1417592-2026-07998
- SENSICAREJul 28, 2026MalfunctionMedline Industries, Lp1417592-2026-07951
- MEDLINEJul 27, 2026MalfunctionMedline Industried Lp1417592-2026-07912
- MEDLINEJul 27, 2026MalfunctionMedline Industried Lp1417592-2026-07924
- MEDLINEJul 20, 2026MalfunctionMedline Industried Lp1417592-2026-06749
- MEDLINEJul 14, 2026MalfunctionMedline Industried Lp1417592-2026-05645
Event type breakdown
Recalls
44 recall events for this product code
- Medline Industries, LPOpen, ClassifiedApr 7, 2026
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows:
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Z-1725-2026 · View FDA record ↗ - Ansell Healthcare Products LLCOpen, ClassifiedOct 11, 2023
GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290
Some surgical glove sterile pouches were not completely sealed.
Z-0096-2024 · View FDA record ↗ - Ansell Healthcare Products LLCOpen, ClassifiedOct 11, 2023
NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290
Some surgical glove sterile pouches were not completely sealed.
Z-0097-2024 · View FDA record ↗ - Cardinal Health 200, LLCCompletedAug 28, 2020
PROTEXIS Latex Micro Surgical Gloves Size 5.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber inte
A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
Z-2912-2020 · View FDA record ↗ - Cardinal Health 200, LLCCompletedAug 28, 2020
PROTEXIS Latex Micro Surgical Gloves Size 6.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber inte
A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
Z-2913-2020 · View FDA record ↗ - Cardinal Health 200, LLCCompletedAug 28, 2020
PROTEXIS Latex Micro Surgical Gloves Size 6.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber inte
A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
Z-2914-2020 · View FDA record ↗ - Cardinal Health 200, LLCCompletedAug 28, 2020
PROTEXIS Latex Micro Surgical Gloves Size 7.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber inte
A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
Z-2915-2020 · View FDA record ↗ - Cardinal Health 200, LLCCompletedAug 28, 2020
PROTEXIS Latex Micro Surgical Gloves Size 7.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber inte
A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
Z-2916-2020 · View FDA record ↗ - Cardinal Health 200, LLCCompletedAug 28, 2020
PROTEXIS Latex Micro Surgical Gloves Size 8.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber inte
A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
Z-2917-2020 · View FDA record ↗ - Cardinal Health 200, LLCCompletedAug 28, 2020
PROTEXIS Latex Micro Surgical Gloves Size 8.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber inte
A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
Z-2918-2020 · View FDA record ↗
Registered firms
820 firms currently registered for this product code
Motex Healthcare (anhui) Co., Ltd.
Guangde City, Xuancheng City Anhui, CN
Hartalega Ngc Sdn. Bhd. (lot 39496)
Sepang Selangor, MY
Prestige Ameritech
North Richland Hills, TX, US
Molnlycke Health Care Sdn Bhd
KULIM Kedah, MY
Veenak International Limited
BIRMINGHAM, GB
Ansell Healthcare Products Llc
Reno, NV, US
Synergy Health Ede Bv
Venlo Limburg, NL
Mainline Medical Dental Supply
North York Ontario, CA
Hartalega Sdn Bhd
Bestari Jaya Selangor, MY
Tg Medical Sdn Bhd
KLANG Selangor, MY
Hartalega Ngc Sdn Bhd
Sepang Selangor, MY
Saint Jones Management Lp Eood
Sofia Sofia-Grad, BG
Synergy Sterilisation Rawang (m) Sdn. Bhd.
Rawang Selangor, MY
Tg Worldwide Sdn. Bhd.
Shah Alam Selangor, MY
Worldwide Supplies Limited
Hong Kong, HK
Cardinal Health
Hazelwood, MO, US
St.marys Rubbers Pvt Ltd
Kottayam Kerala, IN
Wrp Asia Pacific Sdn. Bhd.
SALAK TINGGI, SEPANG Selangor, MY
Sterigenics U.s., Llc
Ontario, CA, US
Brightway Holdings Sdn. Bhd.
KLANG, Selangor, MY
Cardinal Health 200, Llc
Waukegan, IL, US
Medline Industries, Lp - Northfield
Northfield, IL, US
510(k) clearances
560 clearances for this product code
- Hartalega NGC Sdn. Bhd.Jul 28, 2026
K260558 · Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- Protect Gloves Company LimitedMay 22, 2026
K253060 · Sterile Latex Powder Free Surgical Gloves
- Harps Europe Manufacturing GmbHAug 19, 2025
K250313 · Sterile Powder Free Synthetic Rubber Surgeons Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid
- Suzhou Colour-Way New Material Co., Ltd.Aug 23, 2024
K240790 · Polyisoprene Surgical gloves
- Wrp Asia Pacific Sdn. Bhd.Mar 28, 2024
K232079 · Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl
- Grand Work Plastic Products Co., Ltd.Dec 20, 2023
K232444 · Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs
- Ansell HealthcareOct 20, 2023
K231902 · GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090)
- Ineo Tech Sdn BhdSep 29, 2023
K231973 · PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove