(86 days)
The glove is disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves were tested for use with Chemotherapy drugs, Fentanyl and Gastric acid in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue) is a Class I patient examination glove and specialty chemotherapy gloves, that made from synthetic nitrile latex. They are non-sterile, powder-free, fingertip textured, ambidextrous with beaded cuff, and single use only, and come in different sizes- XS, S, M, L, XL and XXL.
The provided [K243441](https://510k.innolitics.com/search/K243441) document is a 510(k) premarket notification for Nitrile Powder-Free Exam Gloves. This type of device is a Class I medical device and does not involve AI or complex algorithms requiring human-in-the-loop studies or ground truth established by experts.
Therefore, most of the requested information regarding AI/algorithm performance, human reader studies, and expert-established ground truth is not applicable to this document. The "device" in this context is a physical examination glove, not an AI-powered diagnostic tool.
The acceptance criteria and performance are related to the physical properties and barrier efficacy of the gloves, not to analytical or diagnostic performance of an algorithm.
However, I can extract the relevant acceptance criteria and reported performance for the physical glove testing:
Acceptance Criteria and Reported Device Performance
As the device is a physical medical glove and not an AI/software device, the acceptance criteria and performance relate to its physical and chemical barrier properties.
Table of Acceptance Criteria and Reported Device Performance:
| Test Performed | Methodology | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| Physical Properties | |||
| Freedom From Holes | ASTM D6319-19, ASTM D5151-19 | Meet requirement inspection level G-I, AQL 2.5 (ISO2859-1) | Pass |
| Dimension - Length | ASTM D6319-19 | Minimum 220mm for size XS-S; Minimum 230mm for size M-XXL | Pass |
| Dimension - Width | ASTM D6319-19 | XS: 70±10mm; S: 80±10mm; M: 95±10mm; L: 110±10mm; XL: 120±10mm; XXL: 130±10mm | Pass |
| Dimension - Thickness | ASTM D6319-19 | Finger: 0.05mm (min); Palm: 0.05mm (min) | Pass |
| Physical properties (Tensile Strength) | ASTM D6319-19, ASTM D412-16 | Min 14MPa (Before aging & After aging) | Pass |
| Physical properties (Ultimate Elongation) | ASTM D6319-19, ASTM D412-16 | Min 500% (Before aging); Min 400% (After aging) | Pass |
| Powder Residue | ASTM D6319-19, ASTM D6124-06 | Not more than 2 mg per glove | Pass |
| Biocompatibility | |||
| Skin Irritation | ISO10993-23:2021 | Not a primary skin irritant | Pass |
| Skin Sensitization | ISO10993-10:2021 | Not a contact sensitizer | Pass |
| Acute Systemic Toxicity | ISO 10993-11:2017 | No acute systemic toxicity | Pass |
| Permeation Testing | |||
| Chemotherapy Drug, Fentanyl, Gastric Acid | ASTM D6978-05 | Minimum Breakthrough Detection Time (minutes) - Specific values for each substance | See detailed tables below |
Detailed Permeation Performance (Minimum Breakthrough Detection Time in minutes):
(Light Blue Glove)
| Chemotherapy Drug | Minimum Breakthrough Detection Time (minutes) |
|---|---|
| Bendamustine HCl, 5 mg/ml | >240 |
| Bortezomib, 1 mg/ml | >240 |
| Busulfan, 6 mg/ml | >240 |
| Carboplatin, 10 mg/ml | >240 |
| Carmustine, 3.3 mg/ml | 16.6 |
| Carfilzomib, 2 mg/ml | >240 |
| Cetuximab (Erbitux), 2 mg/ml | >240 |
| Chloroquine, 50mg/ml | >240 |
| Cisplatin, 1 mg/ml | >240 |
| Cladribine, 1.0 mg/ml | >240 |
| Cyclophosphamide, 20 mg/ml | >240 |
| Cyclosporin A,100mg/ml | >240 |
| Cytarabine HCl, 100 mg/ml | >240 |
| Cytovene, 10 mg/ml | >240 |
| Dacarbazine, 10 mg/ml | >240 |
| Daunorubicin HCl, 5 mg/ml | >240 |
| Decitabine, 5 mg/ml | >240 |
| Docetaxel, 10 mg/ml | >240 |
| Doxorubicin HCl, 2 mg/ml | >240 |
| Epirubicin HCl, 2 mg/ml | >240 |
| Etoposide, 20 mg/ml | >240 |
| Fludarabine, 25 mg/ml | >240 |
| Fluorouracil, 50 mg/ml | >240 |
| Gemcitabine HCl, 38 mg/ml | >240 |
| Idarubicin HCl, 1 mg/ml | >240 |
| Ifosfamide, 50 mg/ml | >240 |
| Irinotecan HCl, 20 mg/ml | >240 |
| Mechlorethamine HCl, 1 mg/ml | >240 |
| Melphalan HCl, 5 mg/ml | >240 |
| Methotrexate, 25 mg/ml | >240 |
| Mitomycin-C, 0.5 mg/ml | >240 |
| Mitoxantrone HCl, 2 mg/ml | >240 |
| Oxaliplatin, 2 mg/ml | >240 |
| Paclitaxel, 6 mg/ml | >240 |
| Retrovir, 10 mg/ml | >240 |
| ThioTEPA, 10 mg/ml | 44.9 |
| Trisenox, 1 mg/ml | >240 |
| Vidaza (Azacitidine),25 mg/ml | >240 |
| Vincristine Sulfate, 1 mg/ml | >240 |
| Fentanyl Citrate Injection, 100mcg/2ml | >240 |
| Simulated Gastric Acid | >240 |
Warning: Do not use Light Blue glove with Carmustine (16.6 minutes) and ThioTEPA (44.9 minutes).
(Dark Blue Glove)
| Chemotherapy Drug | Minimum Breakthrough Detection Time (minutes) |
|---|---|
| Bendamustine HCl, 5 mg/ml | >240 |
| Bortezomib, 1 mg/ml | >240 |
| Busulfan, 6 mg/ml | >240 |
| Carboplatin, 10 mg/ml | >240 |
| Carmustine, 3.3 mg/ml | 21.5 |
| Carfilzomib, 2 mg/ml | >240 |
| Cetuximab (Erbitux), 2 mg/ml | >240 |
| Chloroquine, 50mg/ml | >240 |
| Cisplatin, 1 mg/ml | >240 |
| Cladribine, 1.0 mg/ml | >240 |
| Cyclophosphamide, 20 mg/ml | >240 |
| Cyclosporin A,100mg/ml | >240 |
| Cytarabine HCl, 100 mg/ml | >240 |
| Cytovene, 10 mg/ml | >240 |
| Dacarbazine, 10 mg/ml | >240 |
| Daunorubicin HCl, 5 mg/ml | >240 |
| Decitabine, 5 mg/ml | >240 |
| Docetaxel, 10 mg/ml | >240 |
| Doxorubicin HCl, 2 mg/ml | >240 |
| Epirubicin HCl, 2 mg/ml | >240 |
| Etoposide, 20 mg/ml | >240 |
| Fludarabine, 25 mg/ml | >240 |
| Fluorouracil, 50 mg/ml | >240 |
| Gemcitabine HCl, 38 mg/ml | >240 |
| Idarubicin HCl, 1 mg/ml | >240 |
| Ifosfamide, 50 mg/ml | >240 |
| Irinotecan HCl, 20 mg/ml | >240 |
| Mechlorethamine HCL, 1 mg/ml | >240 |
| Melphalan HCl, 5 mg/ml | >240 |
| Methotrexate, 25 mg/ml | >240 |
| Mitomycin-C, 0.5 mg/ml | >240 |
| Mitoxantrone HCl, 2 mg/ml | >240 |
| Oxaliplatin, 2 mg/ml | >240 |
| Paclitaxel, 6 mg/ml | >240 |
| Retrovir, 10 mg/ml | >240 |
| ThioTEPA, 10 mg/ml | 17.9 |
| Trisenox, 1 mg/ml | >240 |
| Vidaza (Azacitidine),25 mg/ml | >240 |
| Vincristine Sulfate, 1 mg/ml | >240 |
| Fentanyl Citrate Injection, 100mcg/2ml | >240 |
| Simulated Gastric Acid | >240 |
Warning: Do not use Dark Blue glove with Carmustine (21.5 minutes) and ThioTEPA (17.9 minutes).
Regarding the other requested information (which is not applicable to this physical device):
- 2. Sample size(s) used for the test set and the data provenance: Not explicitly stated as "sample size" in a statistical sense for AI. Testing involves physical samples of gloves manufactured for the purpose of meeting ASTM standards. Data provenance is implied to be from laboratory testing according to the listed ASTM and ISO standards.
- 3. Number of experts used to establish the ground truth...: Not applicable. Ground truth for physical properties and chemical permeation is established by standardized laboratory testing procedures (e.g., measuring dimensions, tensile strength, or breakthrough time), not by expert consensus on images or medical data.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication is not relevant for objective laboratory measurements.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done...: Not applicable. This is a physical product, not an AI or imaging device that would involve human readers.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device is based on objective measurements and established physical/chemical standards (e.g., ASTM, ISO), not expert medical interpretation or clinical outcomes data in the context of an AI device.
- 8. The sample size for the training set: Not applicable. There is no training set as this is not an AI/ML device.
- 9. How the ground truth for the training set was established: Not applicable. There is no training set.
§ 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.