Chrysalis Intelligence · Product Codes · KGO

KGO · Unclassified

54 clearances · 31 unique sponsors

Device class
Regulation —
Total clearances
54
2020-02-28 → 2026-07-28
Last 12 months
2
Unique sponsors
31
Medical specialty
Review panel
Regulation number
Implant
Life-sustain / support
GMP exempt
Third-party review
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Medline Industries, Inc. 8 0 2021-08-02
Wrp Asia Pacific Sdn. Bhd. 4 0 2024-03-28
Careplus (M) Sdn Bhd 4 0 2021-10-06
Molnlycke Health Care Us, LLC 3 0 2020-11-22
Hartalega NGC Sdn. Bhd. 3 1 2026-07-28
Suzhou Colour-Way New Material Co., Ltd. 2 0 2024-08-23
Hartalega Sdn Bhd 2 0 2020-10-02
Guilin Hbm Health Protections, Inc. 2 0 2022-09-13
Jr Engineering & Medical Technologies (M) Sdn. Bhd. 2 0 2023-04-13
Ansell Healthcare Products, LLC 2 0 2023-08-23
Grand Work Plastic Products Co., Ltd. 2 0 2023-12-20
Amazing Rubber Products Pvt, Ltd. 1 0 2022-03-01
Mrk Healthcare Pvt, Ltd. 1 0 2021-11-03
Semperit Technische Produkte Gesellchaft M.B.H. 1 0 2020-03-31
Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. 1 0 2022-05-25
The Egyptian Company For Medical & Electronic Industries 1 0 2023-08-16
Fitone Latex Products Co., Ltd. Guangdong 1 0 2023-09-22
Ansell Healthcare 1 0 2023-10-20
Gx Corporation Sdn Bhd 1 0 2021-07-09
Ineo Tech Sdn Bhd 1 0 2023-09-29
Protect Gloves Company Limited 1 1 2026-05-22
Aspen Glove Sdn. Bhd. 1 0 2021-09-16
New Era Medicare Sdn. Bhd. 1 0 2023-01-26
Pentavest Holdings Sdn Bhd 1 0 2021-12-27
Eco Medi Glove Sdn. Bhd. 1 0 2021-02-17
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
A4149 HCPCS High Standard HCPCS code for sterile gloves for medical use
97161 CPT Low CPT for surgical procedure where gloves billed separately (context-dependent)
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-07-28 K260558 Hartalega NGC Sdn. Bhd. 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
2026-05-22 K253060 Protect Gloves Company Limited Sterile Latex Powder Free Surgical Gloves
2025-08-19 K250313 Harps Europe Manufacturing GmbH Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid
2024-08-23 K240790 Suzhou Colour-Way New Material Co., Ltd. Polyisoprene Surgical gloves
2024-03-28 K232079 Wrp Asia Pacific Sdn. Bhd. 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
2023-12-20 K232444 Grand Work Plastic Products Co., Ltd. Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs
2023-10-20 K231902 Ansell Healthcare 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)
2023-09-29 K231973 Ineo Tech Sdn Bhd PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove
2023-09-22 K231446 Fitone Latex Products Co., Ltd. Guangdong Single-Use Latex Sterile Surgical Gloves (SG100)
2023-08-31 K230578 Wrp Asia Pacific Sdn. Bhd. Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl
2023-08-23 K230079 Ansell Healthcare Products, LLC Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential
2023-08-18 K222993 Sentienx Sdn Bhd 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
2023-08-16 K230832 The Egyptian Company For Medical & Electronic Industries Powdered Free Sterile Natural Rubber Latex Surgical Gloves
2023-08-09 K230304 Puyang Linshi Medical Supplies Co., Ltd. Polyisoprene Surgical Gloves
2023-05-26 K213289 Ansell Healthcare Products, LLC Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs
2023-05-13 K230217 Grand Work Plastic Products Co., Ltd. Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs
2023-04-13 K222350 Jr Engineering & Medical Technologies (M) Sdn. Bhd. Sterile Nitrile Surgical Gloves Powder Free
2023-03-23 K222620 Suzhou Colour-Way New Material Co., Ltd. Sterilized Latex Surgical Gloves
2023-01-26 K221424 New Era Medicare Sdn. Bhd. Sterile Surgical Powder Free Latex Glove
2022-10-22 K222058 Wrp Asia Pacific Sdn. Bhd. Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant
2022-09-24 K221718 Hartalega NGC Sdn. Bhd. Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural)
2022-09-13 K221748 Guilin Hbm Health Protections, Inc. Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves
2022-05-26 K214074 Hartalega NGC Sdn. Bhd. Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs
2022-05-25 K211953 Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. Disposable Sterilized Latex Surgical Gloves
2022-03-01 K212596 Amazing Rubber Products Pvt, Ltd. Sterile Latex Surgical Gloves Powder Free