(98 days)
The Sterile Nitrile Patient Examination gloves, Powder free, Blue color, is a disposable device intended for medical purposes that is worn on the examiners' hand or finger to prevent contamination between patient and examiner.
The subject device is a patient examination glove made of synthetic nitrile latex compound. It is sterile, Powder free and is Blue in colour. The device is ambidextrous and can be worn on either the left or right hand. The device meets ASTM D6319-10: Standard specification for Nitrile Examination Gloves for Medical Application. The subject device is substantially equivalent to legally marketed Nitrile examination gloves identified as Product code LZA. The device is for over-the counter single use.
The provided document describes the Sanrea Healthcare Products Pvt Ltd's Sterile Nitrile Patient Examination Gloves, Powder free, Blue color, and its equivalence to a predicate device. The information details the performance testing and acceptance criteria for this Class I medical device.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Test Standard / Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Freedom from Holes | ASTM D6319-10 / ASTM D5151-06 (Reapproved 2011) with Sampling plan / Inspection level / AQL: ISO 2859-1 / G1/AQL 2.5; FDA 1000 ml water leak test | Meets / PASS |
| Dimensions: Length | ASTM D6319-10; ISO 2859-1 / S2/AQL 4.0; > 230 mm | Meets / PASS (> 230 mm) |
| Dimensions: Width | ASTM D6319-10; ISO 2859-1 / S2/AQL 4.0; 70±10 mm to 120±10 mm (sizes XS to XL) | Meets / PASS (70±10 mm to 120±10 mm - sizes XS to XL) |
| Physical Properties: Thickness | ASTM D6319-10; ISO 2859-1 / S2/AQL 4.0; > 0.05 mm (palm & finger) | Meets / PASS (> 0.05 mm - palm & finger) |
| Physical Properties: Tensile strength (Before aging) | ASTM D6319-10 and ASTM D412-06; ISO 2859-1 / S2/AQL 4.0; > 14 Mpa | Meets / PASS (> 14 Mpa) |
| Physical Properties: Ultimate Elongation (Before aging) | ASTM D6319-10 and ASTM D412-06; ISO 2859-1 / S2/AQL 4.0; > 500% | Meets / PASS (> 500%) |
| Physical Properties: Tensile strength (After Accelerated Aging) | ASTM D6319-10 and ASTM D412-06; ISO 2859-1 / S2/AQL 4.0; > 14 Mpa (Aging done at 70 ±2 deg C for 166±2 hrs or 100±2deg C for 22±0.3 hrs) | Meets / PASS (> 14 Mpa) |
| Physical Properties: Ultimate Elongation (After Accelerated Aging) | ASTM D6319-10 and ASTM D412-06; ISO 2859-1 / S2/AQL 4.0; > 400% (Aging done at 70 ±2 deg C for 166±2 hrs or 100±2deg C for 22±0.3 hrs) | Meets / PASS (> 400%) |
| Powder-free residue | ASTM D6319-10 and ASTM D6124-06; N=5; Less than 2 mg per glove | Meets / PASS (Less than 2 mg per glove) |
| Biocompatibility: Primary skin irritation | ISO 10993-10; Under the conditions of the study, the device is not an irritant. | Non-irritant / PASS (Under the conditions of the study, the device is not an irritant.) |
| Biocompatibility: Skin Sensitization | ISO 10993-10; Under the conditions of the study, the device is not a sensitizer. | Non-sensitizer / PASS (Under the conditions of the study, the device is not a sensitizer.) |
| Expiration dating/Shelf life | ASTM D7160-05 | Three years |
| Sterilization | ISO 11135-2014(E) (Ethylene Oxide) | Meets |
| Sterility | ISO 11737-2; Test of sterility performed in the definition, validation and maintenance of sterilization process. | Sterile / PASS |
2. Sample size used for the test set and the data provenance
- Sample Size for Physical Properties and Freedom from Holes: The sample sizes are generally cited within the "Sampling plan / Inspection level / AQL" column. For example, for "Freedom from Holes," it refers to "ISO 2859-1 / G1/AQL 2.5." For "Dimensions" and "Physical Properties," it refers to "ISO 2859-1 / S2/AQL 4.0." For "Powder-free residue," N=5 is used. The specific number of gloves tested within these AQL standards is not explicitly stated as a single number but is dictated by the standard.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. The manufacturer is SANREA HEALTHCARE PRODUCTS PVT LTD, located in Palakkad, Kerala, India. It can be inferred that the testing was conducted either internally by the manufacturer or by a third-party laboratory, likely in India, to demonstrate compliance with the cited ASTM and ISO standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable to this type of device (patient examination gloves). The "ground truth" for these tests is established by objective physical, chemical, and biological measurements performed according to recognized international standards (ASTM, ISO). There is no interpretation by human experts required to establish a diagnostic ground truth, unlike with image-based AI devices.
4. Adjudication method for the test set
This is not applicable as the tests are objective measurements against defined physical, chemical, and biological criteria, not subjective interpretations requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. This document describes a medical device (examination gloves) that does not incorporate AI or involve human readers for diagnostic interpretation. Therefore, an MRMC study is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is an inanimate object (nitrile gloves) and does not involve any algorithms.
7. The type of ground truth used
The "ground truth" for the performance claims of these gloves is based on:
- Standardized Physical Measurements: Length, width, thickness, tensile strength, ultimate elongation performed according to ASTM D6319-10 and ASTM D412-06.
- Standardized Chemical Measurements: Powder-free residue performed according to ASTM D6124-06.
- Standardized Biological Testing: Biocompatibility (primary skin irritation and skin sensitization) performed according to ISO 10993-10, and sterility testing according to ISO 11737-2.
- Performance Tests: Freedom from holes measured by FDA 1000 ml water leak test and ASTM D5151-06.
8. The sample size for the training set
This is not applicable. There is no "training set" for this type of medical device as it does not involve machine learning or AI algorithms. The performance is assessed through direct physical, chemical, and biological testing of manufactured samples.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for this device.
§ 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.