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510(k) Data Aggregation
(413 days)
The Sterile Latex Surgical Gloves, Powder free, is a disposable device made of natural rubber; intended for medical purposes that is worn by operating room personnel to protect a surgical wound from contamination.
The subject device is a surgical glove made of natural rubber latex compound. It is sterile, Powder free. The device is anatomic and is hand specific. The device meets ASTM D3577 – 09 : Standard specification for Rubber Surgical Gloves. The device is for over-the counter single use.
The provided document is a 510(k) premarket notification for Sterile Latex Surgical Gloves, Powderfree. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness or performance for an AI/ML-based device.
Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device (e.g., sample size for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) is not applicable to this document.
The document primarily addresses the following for medical devices like surgical gloves:
- Acceptance Criteria & Device Performance: This section is presented as a comparison table against the predicate device and relevant ASTM/ISO standards.
- Non-Clinical Testing: The study proves the device meets acceptance criteria through various standardized tests.
Here's the relevant information extracted from the document concerning the acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance
| Characteristics | Test Standard | Acceptance Criteria (from Standard) | Reported Device Performance (Sterile Latex Surgical Gloves, Powderfree) | Result |
|---|---|---|---|---|
| Freedom from Holes | ASTM D3577-09 / ASTM D5151-06 (Re-approved 2011) / FDA 1000ml water leak test | Sampling plan/Inspection level/AQL: ISO 2859-1 / G1/AQL 2.5 (for FDA 1000 ml water leak test) | PASS (for FDA 1000ml water leak test) | PASS |
| Dimensions: Length | ASTM D3577-09 | Sampling plan/Inspection level/AQL: ISO 2859-1 / S2/AQL 4.0 ; Overall length min 265 mm | > 265 mm | PASS |
| Dimensions: Width | ASTM D3577-09 | Sampling plan/Inspection level/AQL: ISO 2859-1 / S2/AQL 4.0 ; Varies from 76 mm for 6.0 size to 114 mm for 9.0 size (76±6 mm to 114±6 mm for sizes 6.0 to 9.0) | 76±6 mm to 114±6 mm (sizes 6.0 to 9.0) | PASS |
| Dimensions: Thickness | ASTM D3577-09 | Sampling plan/Inspection level/AQL: ISO 2859-1 / S2/AQL 4.0 ; Minimum 0.10mm (Cuff, palm & finger) | > 0.10 mm (Cuff, palm& finger) | PASS |
| Physical Properties: Before aging | ASTM D3577-09 and ASTM D412-06 | Sampling plan/Inspection level/AQL: ISO 2859-1 / S2/AQL 4.0 ; Tensile strength 24 Mpa min; Ultimate elongation 750% min | Tensile strength : > 24 Mpa ; Ultimate Elongation : >750% | PASS |
| Physical Properties: After Accelerated aging | ASTM D3577-09 and ASTM D573-04 | Sampling plan/Inspection level/AQL: ISO 2859-1 / S2/AQL 4.0 ; Tensile strength 18 Mpa min; Ultimate elongation 560 % min | Tensile strength : > 18 Mpa ; Ultimate Elongation : > 560% | PASS |
| Powder-free residue | ASTM D3577-09 and ASTM D6124-06 | Sampling plan: N=5 ; Less than 2 mg per glove | Less than 2 mg per glove | PASS |
| Biocompatibility: Primary skin irritation | ISO 10993-10 | Under the conditions of the study the device is not an irritant | Under the conditions of the study the device is not an irritant | PASS |
| Biocompatibility: Skin Sensitization | ISO 10993-10 | Under the conditions of the study the device is not a sensitizer | Under the conditions of the study the device is not a sensitizer | PASS |
| Sterility | ISO-11737-2 | Sterile | Sterile | PASS |
| EO Residue | ISO 10993-07:2008 | Maximum limit of EO Residue : 0.0025mg/device | Meets | Meets |
| ECH Residue | ISO 10993-07:2008 | Maximum limit of ECH Residue : 0.0025mg/device | Meets | Meets |
| Expiration dating/Shelf life | ASTM D7160-05 | Not explicitly stated in criteria table, but mentioned as "Three years" | Three years | Meets |
| Sterilization | ISO 11135-2014(E) | Requirements for the development, validation and routine control of a sterilization process for medical devices | Meets | Meets |
2. Sample size used for the test set and the data provenance
- Sample Sizes: Sample sizes are indicated within the "Sampling plan / Inspection level / AQL" columns in the performance data table (e.g., ISO 2859-1 / G1 / AQL 2.5, ISO 2859-1 / S2 / AQL 4.0, N=5 for powder-free residue). For the specific Freedom from Pinholes test, it notes: "Lot Size : 35001 – 150000 pair; Sample size : 200 pair".
- Data Provenance: Not explicitly stated as "country of origin" or "retrospective/prospective" in the context of clinical studies, as this is laboratory/manufacturing performance data. The manufacturer is SANREA HEALTHCARE PRODUCTS PVT LTD, located in Palakkad, Kerala, India.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: This type of testing involves laboratory and physical property measurements against established international standards (ASTM, ISO, FDA). "Ground truth" in this context is defined by the technical specifications and methodologies of these standards, not expert adjudication of medical images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: As above, this pertains to physical and chemical testing against defined standard metrics.
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 premarket notification for a Class I medical device (surgical gloves), not an AI/ML-based diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Standardized Test Methods and Specifications: The "ground truth" for the performance of these gloves is defined by the requirements and test methodologies outlined in the referenced ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards (e.g., ASTM D3577-09 for rubber surgical gloves, ASTM D5151-06 for freedom from holes, ISO 10993 for biocompatibility, ISO 11135 for sterilization). The FDA 1000ml water leak test is also mentioned.
8. The sample size for the training set
- Not Applicable: There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable: There is no "training set" as this is not an AI/ML device.
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