# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Ansell Healthcare
- Decided: Oct 20, 2023 after 114 days
- Product code: KGO (Surgeon'S Gloves)
- Device class: 1
- Regulation: 21 CFR 878.4460
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K071746 (2007). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182948: Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs, Ansell Healthcare Products, LLC (2019) Summary page 6.

## Indications for use
Gammex PI Hybrid Micro Surgical Gloves are sterile, non-pyrogenic, are intended to be worn by operating room personnel to protect a surgical wound from contamination and have a shelf life of 3 years. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Tested chemotherapy drugs are as follows: Test chemotherapy drug and concentration — Minimum breakthrough detection time in minutes Bleomycin (15.0 mg/ml) — >240 Busulfan (6.0 mg/ml) — >240 Carboplatin (10.0 mg/ml) — >240 Carmustine (3.3 mg/ml) — 24.1 Cisplatin (1.0 mg/ml) — >240 Cyclophosphamide (20.0 mg/ml) — >240 Cytarabine HCl (100.0 mg/ml) — >240 Dacarbazine (10.0 mg/ml) — >240 Daunorubicin HCl (5.0 mg/ml) — >240 Docetaxel (10.0 mg/ml) — >240 Doxorubicin HCl (2.0 mg/ml) — >240 Epirubicin (2.0 mg/ml) — >240 Etoposide (20.0 mg/ml) — >240 Fludarabine (25.0 mg/ml) — >240 Fluorouracil (50.0 mg/ml) — >240 Gemcitabine (38.0 mg/ml) — >240 Idarubicin (1.0 mg/ml) — >240 Ifosfamide (50.0 mg/ml) — >240 Irinotecan (20.0 mg/ml) — >240 Mechlorethamine HCI (1.0 mg/ml) — >240 Melphalan (5.0mg/ml) — >240 Methotrexate (25.0 mg/ml) — >240 Mitomycin C (0.5 mg/ml) — >240 Mitoxantrone (2.0mg/ml) — >240 Oxaliplatin (2.0 mg/ml) — >240 Paclitaxel (6.0 mg/ml) — >240 Rituximab (10.0 mg/ml) — >240 ThioTEPA (10.0 mg/ml) — 26.0 Vincristine Sulfate (1.0 mg/ml) — >240 Warning: Do not use with Carmustine or ThioTEPA

Source page: https://510kreport.com/device/K231902
Methodology: https://510kreport.com/methodology