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510(k) Data Aggregation
(83 days)
The Powder-Free Black Examination Glove with Protein Labeling Claim (50 micrograms or less total water extractable protein per gram of glove), is a disposable device intended for Medical Purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
Trade Name: Powder-Free Black Latex Examination Glove With Protein Labeling Claim
Common Name: Examination Gloves
Classification Name: Patient Examination Glove (per 21 CFR 880.6251)
Class 1: Powder-Free Latex examination glove 80LYY that meets all of the requirements of ASTM D3578-05.
Powder Residue: Maximum 2mg/glove
Cuff: Beaded
Material: Latex Material. Latex Quality ASSurancer 11: Com859-1:1999 and manufactured under ISO9001:2000
Overall Length: 240 mm minimum
Width: 95 mm minimum (for medium glove)
Palm Thickness: 0.13 to 0.18mm (at center of palm)
Finger Thickness: 0.15 to 0.20 mm (at 15mm from tip of center finger)
Cuff Thickness: 0.10 to 0.15 mm (at 40mm from the beaded end)
BEFORE AGING Tensile Strength: 21.0 Mpa minimum
BEFORE AGING Ultimate Elongation: 700% minimum
BEFORE AGING Pinhole AQL 1.5 minimum
AFTER AGING 16.0 Mpa minimum
AFTER AGING 500% minimum
AFTER AGING 1.5 minimum
Special Properties: Black Colorant
Packaging: 100 pcs per dispenser box, 10 boxes per case, 1,000 gloves per case
Sizes: XXS — XXL
The provided document describes the acceptance criteria and performance of a Powder-Free Black Latex Examination Glove. It does not describe a study involving an AI-powered device or human readers. Therefore, several requested sections, such as those pertaining to AI model performance, human expert involvement, and training/test set details, are not applicable.
Here's the available information presented in the requested format:
1. A table of acceptance criteria and the reported device performance
| Criteria | Acceptance Criteria (Minimum/Maximum) | Reported Device Performance |
|---|---|---|
| Physical Properties | Meets all requirements of ASTM D3578-05 | Meets all requirements of ASTM D3578-05 |
| Powder Residue | Maximum 2 mg/glove | Not explicitly stated, but "Powder-Free" implies meeting this or better. |
| Overall Length | 240 mm minimum | 240 mm minimum |
| Width (for medium glove) | 95 mm minimum | 95 mm minimum |
| Palm Thickness | 0.13 to 0.18 mm (at center of palm) | 0.13 to 0.18 mm (at center of palm) |
| Finger Thickness | 0.15 to 0.20 mm (at 15mm from tip of center finger) | 0.15 to 0.20 mm (at 15mm from tip of center finger) |
| Cuff Thickness | 0.10 to 0.15 mm (at 40mm from the beaded end) | 0.10 to 0.15 mm (at 40mm from the beaded end) |
| Before Aging | ||
| Tensile Strength | 21.0 Mpa minimum | 21.0 Mpa minimum |
| Ultimate Elongation | 700% minimum | 700% minimum |
| Pinhole AQL | 1.5 minimum | 1.5 minimum |
| After Aging | ||
| Tensile Strength | 16.0 Mpa minimum | 16.0 Mpa minimum |
| Ultimate Elongation | 500% minimum | 500% minimum |
| Pinhole AQL | 1.5 minimum | 1.5 minimum |
| Water Tightness | Meets FDA 1000 ml water test (both before and after aging) | Meets FDA 1000 ml water test (both before and after aging) |
| Protein Labeling Claim | <50 ug/g total water extractable protein per gram of glove | <50 ug/g total water extractable protein per gram of glove |
| Inspection Parameters | ||
| Dimensions | AQL 4.0 | Not explicitly reported as "performance," but stated as an inspection AQL. |
| Physical Properties | AQL 4.0 | Not explicitly reported as "performance," but stated as an inspection AQL. |
| Water Tight Test 1000ml | AQL 1.5 | Not explicitly reported as "performance," but stated as an inspection AQL. |
| Visual Major Defects | AQL 1.5 | Not explicitly reported as "performance," but stated as an inspection AQL. |
| Visual Minor Defects | AQL 2.5 | Not explicitly reported as "performance," but stated as an inspection AQL. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for the specific tests to verify these specifications (e.g., how many gloves were tested for tensile strength or pinholes). It refers to "Inspection Parameters" with AQL (Acceptable Quality Level) values (e.g., G-1 AQL 1.5 for Water Tight Test), which implies a sampling plan based on established quality control standards. However, the exact sample size for the presented performance data is not provided.
Data Provenance: The data is generated from testing of the manufacturer's gloves to demonstrate compliance with ASTM D3578-05 and FDA requirements. It is implied to be prospective testing for regulatory submission. The country of origin of the data is not specified beyond the applicant's US address.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical device (examination glove) subject to physical and chemical property testing against established standards, not an AI-powered diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method for the test set
Not applicable. This is a medical device (examination glove) subject to physical and chemical property testing, not an AI-powered diagnostic device requiring 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 is a medical device (examination glove) and not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (examination glove) and not an AI-powered diagnostic device.
7. The type of ground truth used
The "ground truth" for this device's performance is based on:
- Established industry standards: ASTM D3578-05 for physical properties of latex examination gloves.
- Regulatory requirements: FDA 1000 ml water test.
- Specific claims: Protein labeling claim (<50 ug/g).
- Inspection methods: Specified AQL levels for various quality attributes.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not an AI model.
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