(108 days)
The powder-free Nitrile Surgical Gloves, is a sterile and single use devise made of synthetic rubber intended to be worn by operation room personnel to protect a surgical wound from contamination. The gloves do not contain lubricating or dusting powder.
The subject device is a surgical nitrile qlove made of synthetic nitrile latex compound. It is sterile, powder-free. The device is anatomic. The device meets ASTM D 3577-09: Standard specification for Rubber Surgical gloves for Medical Application. The device is for over-the counter single use.
This document describes the performance data and acceptance criteria for the "Sterile Nitrile Surgical Gloves, Powder-free" manufactured by Primus Gloves Pvt. Limited (K170515).
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Test Standard / Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Freedom from Pinholes | FDA 1000 ml water leak test, ASTM D5151-06 (reap 2011), ISO 2859-1 / G1/AQL 2.5 | PASS |
| Dimensions - Length | ASTM D 3577-09, ISO 2859-1 / S2/AQL 4.0, > 265 mm | PASS (> 265 mm) |
| Dimensions - Width | ASTM D 3577-09, ISO 2859-1 / S2/AQL 4.0, 76±6 mm to 114±6 mm (sizes 6 to 9) | PASS (76±6 mm to 114±6 mm) |
| Dimensions - Thickness | ASTM D 3577-09, ISO 2859-1 / S2/AQL 4.0, > 0.10 mm (Cuff, palm & finger) | PASS (> 0.10 mm) |
| Physical properties - Before aging | ASTM D 3577-09 and ASTM D412-06, ISO 2859-1 / S2/AQL 4.0, Tensile strength: > 17 Mpa, Ultimate Elongation: > 650 %, Stress at 500% Elongation | PASS (> 17 Mpa, > 650 %) |
| Physical properties - After Accelerated aging | ASTM D 3577-09 and ASTM D412-06, ISO 2859-1 / S2/AQL 4.0, Tensile strength: > 12 Mpa, Ultimate Elongation: > 490 % | PASS (> 12 Mpa, > 490 %) |
| Powder-free residue | ASTM D 3577-09 and ASTM D6124-06, N=5, Less than 2 mg per glove | PASS (Less than 2 mg per glove) |
| Biocompatibility - Primary skin irritation | ISO 10993-10, Not an irritant | PASS (Not an irritant) |
| Biocompatibility - Skin/Dermal Sensitization | ISO 10993-10, Not a sensitizer | PASS (Not a sensitizer) |
| Sterility | ISO 11737-02, Sterile (SAL of 10^-6 achieved) | Pass (SAL of 10^-6 achieved) |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Sampling plan/Inspection level/AQL" for some tests:
- Freedom from Pinholes: G1/AQL 2.5 (per ISO 2859-1)
- Dimensions: S2/AQL 4.0 (per ISO 2859-1)
- Physical properties (Before and After aging): S2/AQL 4.0 (per ISO 2859-1)
- Powder-free residue: N=5
The specific total sample sizes (number of gloves tested) for each characteristic are not explicitly stated as a single number but are derived from the specified AQL (Acceptance Quality Limit) and inspection levels per ISO 2859-1.
Data Provenance: The document does not explicitly state the country of origin of the test data (e.g., where the testing labs are located) or whether the data is retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This document describes the testing of a medical device (surgical gloves) against recognized consensus standards (ASTM, ISO, FDA). The "ground truth" for these tests are the objective measurements and pass/fail criteria defined by these standards, not expert consensus on medical images or clinical outcomes.
4. Adjudication Method for the Test Set:
Not applicable. The tests performed are objective measurements (e.g., dimensions, tensile strength, leak test) against defined numerical or qualitative standards. There is no mention of, nor a need for, human adjudication for these types of tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation devices to assess the impact on human reader performance. The device here is a physical product (surgical gloves).
6. If a Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, the studies conducted are standalone performance studies of the device itself, without human-in-the-loop performance. The various physical, chemical, and biological tests assess the inherent properties and performance of the glove.
7. The Type of Ground Truth Used:
The "ground truth" used for these studies is based on:
- Consensus Standards: Specifically ASTM D 3577-09, ASTM D412-06, ASTM D5151-06 (reap 2011), ASTM D6124-06, ISO 2859-1, ISO 10993-10, and ISO 11737-02.
- Defined Pass/Fail Criteria: Each test has numerical or qualitative criteria for what constitutes a "PASS" (e.g., tensile strength > 17 Mpa, less than 2 mg powder per glove, not an irritant).
8. The Sample Size for the Training Set:
Not applicable. This device is a physical product (surgical gloves) and does not involve AI/machine learning algorithms that require a "training set" in the context of image analysis or diagnostic models. The manufacturing process itself (which is optimized over time) could be considered a form of "training," but not in the data science sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" in the context of AI/ML for this device. The quality control and manufacturing processes ensure the product consistently meets the established standards.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).