(263 days)
Black Pearl Nitrile Examination Glove is a disposable device, intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Black Pearl Nitrile Examination Glove is a single use examination glove, intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The nitrile glove is an ambidextrous, beaded cuff and black in colour. It meets the performance requirements in accordance with ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
This looks like a 510(k) Premarket Notification for a medical device (Black Pearl Nitrile Examination Glove). For this type of device, the acceptance criteria and supporting studies are focused on performance, safety, and biocompatibility, rather than clinical efficacy studies often seen with AI/ML devices.
Here's an analysis of the provided information, framed by your request:
Acceptance Criteria and Study for Black Pearl Nitrile Examination Glove
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against the standards ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Applications) and ASTM D6124-06 (Reapproved 2017) (Standard Test Method for Residual Powder on Medical Gloves).
| Test Performed | Applicable Standard | Acceptance Criteria | Reported Device Performance | Status |
|---|---|---|---|---|
| Dimensions | ASTM D6319-19 | Length: XS, S: Min. 220mm; M, L, XL: Min. 230mm | Length: XS: Min. 242mm; S: Min. 244mm; M: Min. 241mm; L: Min. 240mm; XL: Min. 241mm | Pass |
| Width: XS: 70mm ±10mm; S: 80mm ±10mm; M: 95mm ±10mm; L: 110mm ±10mm; XL: 120mm ±10mm | Width: XS: 77-80mm; S: 83-86mm; M: 96-98mm; L: 107-110mm; XL: 119-124mm | Pass | ||
| Thickness: Palm - Min. 0.05mm; Finger - Min. 0.05mm | Thickness: Palm - Min. 0.06mm; Finger - Min. 0.08mm (for all sizes tested) | Pass | ||
| Freedom from Holes | ASTM D6319-19 | Sample size: 200 pcs, Inspection level: G-I, AQL: 2.5, Accept: ≤ 10 pieces, Reject: ≥ 11 pieces | 2 pieces were found with holes (within acceptance). | Pass |
| Physical Properties | ASTM D6319-19 | Before Aging: Tensile Strength: Min. 14 MPa; Ultimate Elongation: Min. 500% | ||
| After Accelerated Aging: Tensile Strength: Min. 14 MPa; Ultimate Elongation: Min. 400% | Before Aging: Tensile Strength: Min. 18.2 MPa; Ultimate Elongation: Min. 500% | |||
| After Accelerated Aging: Tensile Strength: Min. 17.4 MPa; Ultimate Elongation: Min. 400% | Pass | |||
| Powder-free Residue | ASTM D6124-06 (Reapproved 2017) | ≤ 2.0 mg/glove | 0.70 mg/glove | Pass |
| Skin Irritation Test | ISO 10993-23:2021(E) (Implied by conclusion) | Non-irritant | Primary irritation index obtained was '0'. No local skin irritation observed. | Pass |
| Skin Sensitization Test | ISO 10993-10:2010(E) (Implied by conclusion) | Non-sensitizer | No skin sensitization reactions observed. | Pass |
| In vitro Cytotoxicity | ISO 10993-5:2009 (Implied by conclusion) | Non-cytotoxic to L-929 cells in 1:16 dilution (6.25%) and 1:32 dilution (3.125%). Acceptably cytotoxic at higher concentrations/lower dilutions (undiluted, 1:2, 1:4, 1:8) for its classification as a surface device with limited contact. (This is a non-standard acceptance criteria interpretation for the table, as the report explicitly states cytotoxicity at higher concentrations). | Cytotoxic in undiluted (100%), 1:2 (50%), 1:4 (25%) and 1:8 dilution (12.5%). Non-cytotoxic to L-929 cells in 1:16 (6.25%) and 1:32 dilution (3.125%). | Pass |
| Acute Systemic Toxicity | ISO 10993-11:2017(E) (Implied by conclusion) | Did not induce any acute systemic toxicity | Did not induce any acute systemic toxicity in swiss albino mice. No clinical toxicity or overt toxicity observed. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Dimensions: 13 pieces of gloves from each size (XS, S, M, L, XL) for each parameter (length, width, thickness). Lot size for sampling was 35,001 to 150,000, with an inspection level of S-2 and AQL of 4.0.
- Freedom from Holes: 200 pieces of M-size gloves. Lot size for sampling was 35,001 to 150,000, with an inspection level of G-1 and AQL of 2.5.
- Physical Properties: 13 pieces of M-size gloves. Lot size for sampling was 35,001 to 150,000, with an inspection level of S-2 and AQL of 4.0.
- Powder-free Residue: 5 pieces of gloves.
- Skin Irritation Test: 6 New Zealand White rabbits (3 for polar extracts, 3 for non-polar extracts).
- Skin Sensitization Test: 30 guinea pigs (5 for polar solvent control, 10 for polar test item extract, 5 for non-polar solvent control, 10 for non-polar test item extract).
- In vitro Cytotoxicity: L-929 mouse fibroblasts cells.
- Acute Systemic Toxicity Test: 20 Swiss Albino mice (4 groups of 5 males each).
Data Provenance: The document does not explicitly state the country of origin for the testing facilities or the specific animal vendors/data source, but the submitter is from Malaysia. These are prospective tests performed specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
These tests are standardized laboratory and in-vivo animal tests, not typically requiring "experts" in the sense of clinical reviewers establishing ground truth for diagnostic or AI systems. The "ground truth" is established by the well-defined and validated methodologies of the ASTM and ISO standards themselves. The results are quantitative measurements or qualitative observations by laboratory personnel trained in those specific methods.
4. Adjudication Method for the Test Set
Not applicable in the context of these types of performance and biocompatibility tests. Results are generally objective measurements or direct observations against a standard, not requiring multi-expert 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
Not applicable. This device is an examination glove, not an AI/ML-based diagnostic system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is an examination glove, not an AI/ML-based diagnostic system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for these tests is based on:
- Standardized measurement protocols: For physical dimensions, tensile strength, elongation, and powder residue.
- Defined biological reactions: For freedom from holes (water leak detection) and biocompatibility tests (observed biological responses in animals or cell cultures according to ISO guidelines).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no training set in the typical sense. The performance characteristics of the glove are inherent to its manufacturing process and material properties, validated by testing against established standards.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of 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.