(68 days)
A powder free nitrile examination glove is a disposable device made of synthetic material intended to be worn on the hand for medical purposes to provide barrier against potentially infectious materials and other contaminants. In addition, this product is tested for use with chemotherapy drugs.
Powder Free Nitrile Examination Gloves, White (non-colored) or Blue (colored), Non Sterile (Chemotherapy Drug Protection Labeling Claim) will meet all the current specification for ASTM D6319.
Here's a breakdown of the acceptance criteria and study information for the "Powder Free Nitrile Examination Gloves, White (non-colored) or Blue (colored), Non-Sterile (Chemotherapy Drug Protection Labeling Claim)" based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria / Standard | Device Performance |
|---|---|---|
| Dimensions | ASTM D6319 - 00a(2005)e1 | Meets |
| Physical Properties | ASTM D 412 - 06ae1 | Meets |
| Freedom from pin-holes | ASTM D 5151 - 06 | Meets |
| Powder Free Residue | ASTM D 6124 - 06 | Meets |
| Biocompatibility | Dermal Sensitization (as per ASTM F720-81) | Not a contact skin sensitizer |
| Primary Skin Irritation Test (as per 16CFR Part1500) | Not a primary skin irritant | |
| Chemotherapy Drug Permeation (White Gloves) | Carmustine (BCNU) (3.3mg/ml) breakthrough time | 71.3 minutes |
| Cisplatin (1.0 mg/ml) breakthrough time | >240 minutes | |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) breakthrough time | >240 minutes | |
| Dacarbazine (DTIC) (10.0 mg/ml) breakthrough time | >240 minutes | |
| Doxorubicin Hydrochloride (2.0 mg/ml) breakthrough time | >240 minutes | |
| 5-Fluorouracil (50.0 mg/ml) breakthrough time | >240 minutes | |
| Etoposide (Toposar) (20.0 mg/ml) breakthrough time | >240 minutes | |
| Paclitaxel (Taxol) (6.0 mg/ml) breakthrough time | >240 minutes | |
| ThioTepa (10.0 mg/ml) breakthrough time | 72.36 minutes | |
| Chemotherapy Drug Permeation (Blue Gloves) | Carmustine (BCNU) (3.3mg/ml) breakthrough time | 60.7 minutes |
| Cisplatin (1.0 mg/ml) breakthrough time | >240 minutes | |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) breakthrough time | >240 minutes | |
| Dacarbazine (DTIC) (10.0 mg/ml) breakthrough time | >240 minutes | |
| Doxorubicin Hydrochloride (2.0 mg/ml) breakthrough time | >240 minutes | |
| 5-Fluorouracil (50.0 mg/ml) breakthrough time | >240 minutes | |
| Etoposide (Toposar) (20.0 mg/ml) breakthrough time | >240 minutes | |
| Paclitaxel (Taxol) (6.0 mg/ml) breakthrough time | >240 minutes | |
| ThioTepa (10.0 mg/ml) breakthrough time | 69.0 minutes |
(Note: The document states "Meets" for general characteristics, implying the device performance met the specified ASTM standards. For chemotherapy drug permeation, specific breakthrough times are provided as observed performance.)
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for each specific test (e.g., number of gloves tested for pin-holes, or number of samples for each chemotherapy drug).
The data provenance is from Malaysia, as the submitting company, Wear Safe (Malaysia) Sdn. Bhd., is based in Malaysia. The studies appear to be prospective performance tests conducted on the device to demonstrate compliance with standards and for chemotherapy drug permeation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This device is a physical product (examination gloves), and its performance is assessed against established physical and chemical standards (ASTM, 16CFR). The "ground truth" is defined by the technical specifications and test methodologies outlined in these standards, not by expert consensus in a clinical diagnostic sense. Therefore, no experts in the context of clinical interpretation or diagnosis were used to establish ground truth.
4. Adjudication Method for the Test Set:
Not applicable. As described above, the evaluation is based on objective measurements against established standards, not on subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. An MRMC comparative effectiveness study is designed for evaluating diagnostic tools where human readers interpret medical images or data, often with and without AI assistance. This is not relevant for the performance evaluation of examination gloves.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
Yes, in essence. The performance tests conducted for the gloves are "standalone" in the sense that they assess the intrinsic physical, chemical, and barrier properties of the glove material itself, without human intervention in the interpretation of results beyond standard laboratory procedures. There is no "algorithm" involved, but the device's performance is measured directly.
7. The Type of Ground Truth Used:
The ground truth used is based on established industry standards and regulatory specifications. Specifically:
- ASTM (American Society for Testing and Materials) Standards: For dimensions, physical properties, freedom from pin-holes, and powder-free residue.
- 16CFR Part 1500: For primary skin irritation.
- ASTM F720-81: For dermal sensitization.
- Chemotherapy Drug Permeation Testing: The "ground truth" for the chemotherapy drug claim is the measured breakthrough time of each specified drug through the glove material, which is an objective measurement based on a defined test methodology (though the specific standard for this permeation testing is not explicitly cited in the provided text, it is common practice to follow recognized standards like ASTM D6978).
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device, not an AI or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set was used.
§ 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.