Atlas FDA

Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator Underglove, Biogel PI Micro Indicator Underglove, Biogel PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim

FDA 510(k) clearance K202090 · decided 2020-11-22

Clearance details

K-number
K202090
Device name
Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator Underglove, Biogel PI Micro Indicator Underglove, Biogel PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim
Applicant
Molnlycke Health Care Us, LLC
Decision
Substantially Equivalent
Date received
2020-07-28
Decision date
2020-11-22
Days to decision
117 days
Clearance type
Traditional
Product code
KGO
Device class
1
Regulation number
878.4460
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Peachtree Corners, GA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Molnlycke Health Care Us

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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 (K260558)Hartalega NGC Sdn. Bhd.2026-07-28
Sterile Latex Powder Free Surgical Gloves (K253060)Protect Gloves Company Limited2026-05-22
Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid (K250313)Harps Europe Manufacturing GmbH2025-08-19
Polyisoprene Surgical gloves (K240790)Suzhou Colour-Way New Material Co., Ltd.2024-08-23
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 (K232079)Wrp Asia Pacific Sdn. Bhd.2024-03-28
Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs (K232444)Grand Work Plastic Products Co., Ltd.2023-12-20
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) (K231902)Ansell Healthcare2023-10-20
PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove (K231973)Ineo Tech Sdn Bhd2023-09-29
Single-Use Latex Sterile Surgical Gloves (SG100) (K231446)Fitone Latex Products Co., Ltd. Guangdong2023-09-22
Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (K230578)Wrp Asia Pacific Sdn. Bhd.2023-08-31
Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential (K230079)Ansell Healthcare Products, LLC2023-08-23
Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs; Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, White Tested For Use with 32 Chemotherapy Drugs (K222993)Sentienx Sdn Bhd2023-08-18

Recalls involving this device

No recalls on record reference this clearance.