FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Halyard Pink Underguard Nittile Powder-Free Exam Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with the following chemotherapy drugs:

· Arsenic Trioxide (1 mg/ml) No breakthrough up to 240 minutes
· Azacitidine (Vidaza) (25 mg/ml) No breakthrough up to 240 minutes
· Bendamustine (5 mg/ml) No breakthrough up to 240 minutes
· Bortezomib (Velcade) (1 mg/ml) No breakthrough up to 240 minutes
· Bleomycin sulfate (15 mg/ml) No breakthrough up to 240 minutes
· Busulfan (6 mg/ml) No breakthrough up to 240 minutes
Carboplatin (10 mg/ml) No breakthrough up to 240 minutes
Car-filzomib (2 mg/ml) No breakthrough up to 240 minutes
Cetuximab (Erbitux) (2 mg/ml) No breakthrough up to 240 minutes
· Cisplatin (1 mg/ml) No breakthrough up to 240 minutes
· Cladribine (1.0 mg/ml) No breakthrough up to 240 minutes
· Cyclophosphamide (20 mg/ml) No breakthrough up to 240 minutes
· Cytarabine HCL (100 mg/ml) No breakthrough up to 240 minutes
Cytovene (10 mg/ml) No breakthrough up to 240 minutes
· Dacarbazine (10 mg/ml) No breakthrough up to 240 minutes
· Daunorubicin HCL (5 mg/ml) No breakthrough up to 240 minutes
Decitabine (5 mg/ml) No breakthrough up to 240 minutes
Docetaxel (10 mg/ml) No breakthrough up to 240 minutes
· Doxorubicin HCL (2 mg/ml) No breakthrough up to 240 minutes
· Epirubicin (Ellence) (2 mg/ml) No breakthrough up to 240 minutes
Etoposide (20 mg/ml) No breakthrough up to 240 minutes
Fludarabine (25 mg/ml) No breakthrough up to 240 minutes
· Fluorouracil (50 mg/ml) No breakthrough up to 240 minutes
Fulvestrant (50 mg/ml) No breakthrough up to 240 minutes
· Gemcitabine (38 mg/ml) No breakthrough up to 240 minutes
Idarubicin (1 mg/ml) No breakthrough up to 240 minutes
· Ifosfamide (50 mg/ml) No breakthrough up to 240 minutes
Irinotecan (20 mg/ml) No breakthrough up to 240 minutes
· Mechlorethamine HCL (1 mg/ml) No breakthrough up to 240 minutes
Melphalan (5 mg/ml) No breakthrough up to 240 minutes
· Methotrexate (25 mg/ml) No breakthrough up to 240 minutes
· Mitomycin-C (0.5 mg/ml) No breakthrough up to 240 minutes
· Mitoxantrone (2 mg/ml) No breakthrough up to 240 minutes
Oxaliplatin (2 mg/ml) No breakthrough up to 240 minutes
Paclitaxel (6 mg/ml) No breakthrough up to 240 minutes
Paraplatin (10 mg/ml) No breakthrough up to 240 minutes
Pemetrexed (25 mg/ml) No breakthrough up to 240 minutes
Pertuzumab (30 mg/ml) No breakthrough up to 240 minutes
Raltitrexed (0.5 mg/ml) No breakthrough up to 240 minutes
· Retrovir (10 mg/ml) No breakthrough up to 240 minutes
· Rituximab (10 mg/ml) No breakthrough up to 240 minutes
· Temsirolimus (25 mg/ml) No breakthrough up to 240 minutes
Trastuzumab (21 mg/ml) No breakthrough up to 240 minutes
· Topotecan HCL (1 mg/ml) No breakthrough up to 240 minutes
· Triclosan (2 mg/ml) No breakthrough up to 240 minutes
Trisonex (1.0 mg/ml) No breakthrough up to 240 minutes
· Vincrinstine Sulfate (1 mg/ml) No breakthrough up to 240 minutes
Vinblastine (1 mg/ml) No breakthrough up to 240 minutes
· Vinorelbine (10 mg/ml) No breakthrough up to 240 minutes
· Zoledronic Acid (0.8 mg/ml) No breakthrough up to 240 minutes

CAUTION: The following chemotherapy drugs and concentration showed breakthrough detected in less than 240 minutes:

Carmustine (3.3 mg/ml) No breakthrough up to 54.7 minutes
· ThioTEPA (10 mg/ml) No breakthrough up to 128.5 minutes

Device Description

Halyard® Pink Underguard Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs are disposable, pink-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, non- sterile patient examination gloves that are packed in a cardboard dispenser box.

AI/ML Overview

The device described is the Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Device: Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs

Characteristic / Test Method	Acceptance Criteria (from standard)	Reported Device Performance
ASTM D6978-05
Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs	No signs of breakthrough after 4 hours for 50 drugs, except for Carmustine and ThioTEPA.	Meets Acceptance Criteria:

No breakthrough up to 240 minutes for 50 chemotherapy drugs:
Arsenic Trioxide (1 mg/ml), Azacitidine (Vidaza) (25 mg/ml), Bendamustine (5 mg/ml), Bortezomib (Velcade) (1 mg/ml), Bleomycin sulfate (15 mg/ml), Busulfan (6 mg/ml), Carboplatin (10 mg/ml), Carfilzomib (2 mg/ml), Cetuximab (Erbitux) (2 mg/ml), Cisplatin (1 mg/ml), Cladribine (1 mg/ml), Cyclophosphamide (20 mg/ml), Cytarabine HCL (100 mg/ml), Cytovene (10 mg/ml), Dacarbazine (10 mg/ml), Daunorubicin HCL (5 mg/ml), Decitabine (5 mg/ml), Docetaxel (10 mg/ml), Doxorubicin HCL (2 mg/ml), Ellence (2 mg/ml), Etoposide (20 mg/ml), Fludarabine (25 mg/ml), Fluorouracil (50 mg/ml), Fulvestrant (50 mg/ml), Gemcitabine (38 mg/ml), Idarubicin (1 mg/ml), Ifosfamide (50 mg/ml), Irinotecan (20 mg/ml), Mechlorethamine HCL (1 mg/ml), Melphalan (5 mg/ml), Methotrexate (25 mg/ml), Mitomycin (0.5 mg/ml), Mitoxantrone (2 mg/ml), Oxaliplatin (2 mg/ml), Paclitaxel (6 mg/ml), Paraplatin (10 mg/ml), Pemetrexed (25 mg/ml), Pertuzumab (30 mg/ml), Raltitrexed (0.5 mg/ml), Retrovir (10 mg/ml), Rituximab (10 mg/ml), Temsirolimus (25 mg/ml), Trastuzumab (21 mg/ml), Topotecan HCL (1 mg/ml), Triclosan (2 mg/ml), Trisonex (1.0 mg/ml), Vincrinstine Sulfate (1 mg/ml), Vinblastine (1 mg/ml), Vinorelbine (10 mg/ml), Zoledronic Acid (0.8 mg/ml).
Limited breakthrough times for specific drugs:
Carmustine (3.3 mg/ml): No breakthrough up to 54.7 minutes
ThioTEPA (10 mg/ml): No breakthrough up to 128.5 minutes |
| ASTM D5151-06
Standard Test Method for Detection of Holes in Medical Gloves | 2.5% AQL (Acceptable Quality Limit) for leakage. | Meets the 2.5% AQL requirement for leakage. |
| ASTM D6319-10
Standard Specification for Nitrile Examination Gloves for Medical Applications | Within limits for physical dimensions; meet requirements for tensile strength and elongation. (Specific numerical criteria for tensile strength and elongation are implied by the standard but not fully detailed in the provided text for acceptance, only for performance. For the predicate, 38 MPa tensile strength after aging and 550% elongation after aging are mentioned as targets). | Physical dimensions are within the limits of the standard.
Physical Properties:
Tensile Strength: Average 37.89 MPa before aging, 39.32 MPa after aging.
Elongation: 602% before aging, 558% after aging. |
| ASTM D6124-06
Standard Test Method for Residual Powder on Medical Gloves | Powder-free limit of

Summary

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.