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510(k) Data Aggregation
(128 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand or finger to prevent contamination between patient and examiners.
Latex Examination Gloves Powder Free with Protein Claim
The provided text describes information related to a 510(k) submission for "Latex Examination Gloves Powder Free with Protein Claim" by PT. MAJA AGUNG LATEXINDO. While it details the device and its intended use, it does not explicitly contain a section titled "acceptance criteria and the study that proves the device meets the acceptance criteria" in the format of a clinical study with detailed statistical results.
However, based on the provided text, the acceptance criteria for these gloves are primarily performance requirements and physical characteristics that are expected to meet certain standards, particularly ASTM D 3578-95 and FDA's pinhole requirement. The "study" proving these are met seems to be through non-clinical testing as specified in the document.
Here's an attempt to structure the available information into the requested format, inferring where explicit details are missing:
Acceptance Criteria and Device Performance Study (Inferred from 510(k) Submission)
The acceptance criteria for the Latex Examination Gloves Powder Free with Protein Claim are primarily based on established industry standards and regulatory requirements. The device's performance is demonstrated through non-clinical testing against these specified criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensions (as per ASTM) | Length: min. 240 mm (all sizes) | Length: 240 mm (reported for S, M, L) |
| Palm Width Thickness: Small: 85±10 mm; Medium: 95±10 mm; Large: 111±10 mm | Palm Width Thickness: Small: 85±10 mm; Medium: 95±10 mm; Large: 111±10 mm | |
| Cuff Thickness: min. 0.10 mm | Cuff Thickness: 0.10 mm | |
| Palm Thickness: min. 0.10 mm | Palm Thickness: 0.10 mm | |
| Finger Tip Thickness: min. 0.10 mm | Finger Tip Thickness: 0.10 mm | |
| Physical Properties (as per ASTM) | Tensile Strength (Before Ageing): 21 MPa | Tensile Strength (Before Ageing): 21 Mpa |
| Tensile Strength (After Ageing at 70°C 168 hrs): 16 MPa | Tensile Strength (After Ageing at 70°C 168 hrs): 16 Mpa | |
| Ultimate Elongation (Before Ageing): min. 700 % | Ultimate Elongation (Before Ageing): 700 % (min.) | |
| Ultimate Elongation (After Ageing at 70°C 168 hrs): min. 600 % | Ultimate Elongation (After Ageing at 70°C 168 hrs): 600 % (min.) | |
| Performance Requirements | Watertight: Related Defects: Holes; Inspection Level: S-4; AQL: 2.5 | Meets FDA pin hole requirement |
| Dimensions: Related Defects: Width, Length & Thickness; Inspection Level: S-2; AQL: 4 | Meets specified dimensions | |
| Physical Properties: Related Defects: Before and after ageing; Inspection Level: S-2; AQL: 4 | Meets specified physical properties | |
| Chemical/Biological | Weight of residual powder (medium size gloves): 0.50 ± 0.20 mg | 0.50 ± 0.20 mg |
| Total water extractable protein: 50 microgram/gram (maximum) | 50 microgram/gram (maximum) | |
| Bio-Compatibility: | (Attached as Annexure XII) | |
| Standards Compliance | Meet ASTM D 3578-95 AQL requirements | Test Results as per ASTM D 3578-95 (Attached as Annexure V) |
| Meet FDA pin hole requirement | Meets FDA pin hole requirement | |
| Meets labeling claim | Meets labeling claim |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes for the testing of each criterion. However, it references ASTM D 3578-95 and inspection levels (S-4, S-2) with AQL values (2.5, 4) for performance requirements. These standards typically define the sampling plans and sample sizes for quality control and lot acceptance.
- Provenance: Non-clinical test data generated, likely by the manufacturer (PT. MAJA AGUNG LATEXINDO), in Indonesia. The data is retrospective in the context of this 510(k) submission, as it was generated prior to submission to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable in this context. The "ground truth" for the performance of the gloves is established by objective, standardized tests as per ASTM specifications and FDA requirements, not by expert consensus on subjective observations. The testing would have been conducted by trained laboratory personnel.
4. Adjudication method for the test set
Not applicable. This is not a study requiring adjudication of interpretations (e.g., medical image reading). The results are quantitative measurements against predefined standards.
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 a medical glove, not an AI-assisted diagnostic or decision-support tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device. The device itself is the glove, and its performance is assessed directly through physical and chemical testing.
7. The type of ground truth used
The "ground truth" is defined by objective, quantitative measurements and adherence to established industry standards (e.g., ASTM D 3578-95) and regulatory requirements (e.g., FDA pinhole requirement, protein content limits). This includes:
- Physical measurements (dimensions, tensile strength, elongation)
- Chemical analysis (residual powder, extractable protein)
- Integrity testing (watertightness/pinhole testing)
- Biological testing (biocompatibility, referenced as Annexure XII)
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model, so there is no training set in the AI sense.
9. How the ground truth for the training set was established
Not applicable, as there is no training set. The "ground truth" for the device's performance is established by the accepted international and national standards it claims to meet.
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