(422 days)
This Powdered Latex Surgeon's Glove is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
The glove is made of natural rubber latex. It is powdered with absorbable dusting powder. The sterility status is sterile. It meets all the requirements of ASTM D3577-0951. No colorant is added during manufacture of our Powdered Latex Surgeon's Glove. The color of our glove is ivory.
This document describes a 510(k) premarket notification for a medical device, specifically a Powdered Latex Surgeon's Glove. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through a comprehensive study with acceptance criteria and a detailed statistical analysis typically associated with AI/ML devices or new therapies.
Therefore, many of the requested categories for AI/ML device studies are not applicable to this submission. The device is a physical product (a glove), not a software algorithm or AI.
However, I can extract the relevant information regarding performance specifications and how the device meets established standards.
Device Name: Powdered Latex Surgeon's Glove (Suzhou Colour-way Enterprise Development Co., Ltd)
Predicate Device: Powdered Latex Surgeon's Glove (K062797)
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on demonstrating equivalence to a predicate device and meeting the requirements of established international standards (ASTM D3577-0951, ISO10993-10:2010, and ISO11137-2:2012).
| Characteristic | Acceptance Criteria (Predicate Device / Standard) | Reported New Device Performance (Colour-way's Glove) |
|---|---|---|
| Physical Dimensions: | ||
| Length (various sizes) | Min. 245 mm to Min. 265 mm (depending on size) | 250 |
| Width (various sizes) | 70±6 mm to 114±6 mm (depending on size) | 72±4 mm to 114±6 mm (depending on size) |
| Thickness: | ||
| Cuff | Min. 0.10 mm | 0.21±0.1 mm |
| Palm | Min. 0.10 mm | 0.24±0.1 mm |
| Finger | Min. 0.10 mm | 0.25±0.1 mm |
| Before Ageing: | ||
| Tensile Strength | 24 MPa, min | 33~38 MPa |
| Ultimate Elongation | 750% min | 750~800% |
| Stress at 500% Elongation | 5.5 MPa, max | 5.2~5.4 MPa |
| After Ageing: | ||
| Tensile Strength | 18 MPa, min | 28~34 MPa |
| Ultimate Elongation | 560%, min | 740~810% |
| Water Leak | Inspection Level: I, AQL: 1.5 | Inspection Level: I, AQL: 1.5 |
| Biocompatibility: | ||
| Guinea Pig Maximization | No significant skin sensitization | No significant evidence of causing skin sensitization (as per ISO10993-10) |
| Primary Skin Irritation | Not irritating | Not irritating (as per ISO10993-10) |
| Sterilization Validation: | Meet acceptance criteria | Meet acceptance criteria (as per ISO 11137-2) |
| Powder Content | (Implicit from predicate description) | No more than 15mg/dm² |
| Extractable Protein | (Implicit from predicate description) | No more than 200µg/dm² |
Study Proving Device Meets Acceptance Criteria:
The submission explicitly states: "The Powdered Latex Surgeon's Glove manufactured by Suzhou Colour-way Enterprise Development Co., Ltd and the predicate device meet the technology characteristics of ASTM D3577-0951, ISO10993-10:2010 and ISO11137-2:2012 standards." This indicates that the new device underwent testing to demonstrate compliance with these standards, and a comparison against the predicate device based on the characteristics listed above.
Information Not Applicable to this 510(k) Submission (Device is a Physical Product, not AI/ML):
Given that this is a 510(k) submission for a physical medical device (latex gloves) and not an AI/ML software device, the following categories are not applicable (N/A):
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): N/A – Testing is on physical properties and biocompatibility, not data sets.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): N/A – Ground truth is established by physical measurements and standardized biochemical/biological tests, not expert interpretation of data.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A – Applies to interpretation tasks, not physical product testing.
- 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: N/A – Applies to AI/ML software.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: N/A – Applies to AI/ML software.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A – Ground truth for physical properties are defined by test methods in the standards (e.g., force required to break, elongation percentage, chemical analysis results).
- 8. The sample size for the training set: N/A – Applies to AI/ML software.
- 9. How the ground truth for the training set was established: N/A – Applies to AI/ML software.
Summary of the Study (as presented in the 510(k)):
The "study" in this context is a series of tests performed to demonstrate that the Powdered Latex Surgeon's Glove manufactured by Suzhou Colour-way Enterprise Development Co., Ltd meets the specifications of ASTM D3577-0951, ISO10993-10:2010, and ISO11137-2:2012 standards, and that its technological characteristics (material, design, indications for use, and performance features like dimensions, tensile strength, elongation, water leak, and biocompatibility) are substantially equivalent to the identified predicate device (K062797). The specific details of the testing methodology (e.g., exact number of gloves tested for each property) are not provided in this summary but would be part of the full submission to show compliance with the cited standards. The conclusion explicitly states the device is "as safe and effective and performed as well as the referenced predicate device."
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).