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510(k) Data Aggregation
(248 days)
Powder Free Surgical gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy:
| Test Chemotherapy Drug (Concentration) | Minimum Breakthrough Detection Time in minutes |
|---|---|
| Fluorouracil (50.0mg/ml) | >240 |
| Etoposide (20.0mg/ml) | >240 |
| Cyclophosphamide (20.0mg/ml) | >240 |
| Carmustine (3.3mg/ml) | 13.2 |
| Thiotepa (10.0mg/ml) | 12.0 |
| Paclitaxel (6.0mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0mg/ml) | >240 |
| Methotrexate (25.0mg/ml) | >240 |
| Vincristine Sulfate (1.0mg/ml) | >240 |
"WARNING: Do not use Carmustine and Thiotepa"
It is the powder-free variation of the class I sterile latex surgical gloves made by on-line polymer and anti-tack coating on inner and outer surface. The process modifies the surface istics and causes it to remain tack-free without the use of any dusting or donning powder. The device size comes in different sizes - 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0. Gloves meet the specification of ASTM D3577 with dimension as below:
| Size | 5.5 | 6.0 | 6.5 | 7.0 | 7.5 | 8.0 | 8.5 | 9.0 |
|---|---|---|---|---|---|---|---|---|
| Length, min. mm | 245 | 265 | ||||||
| Thickness, min. mm | 0.10 | |||||||
| Width, ± 6 mm | 70 | 76 | 83 | 89 | 95 | 102 | 108 | 114 |
The provided document is a 510(k) Premarket Notification for a medical device: ENCORE® Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs, Non-Pyrogenic.
This document outlines the testing performed to demonstrate substantial equivalence to a predicate device, focusing on performance characteristics and safety measures for surgical gloves, rather than an AI/ML device that requires acceptance criteria and a study to prove its performance in the context of human improvement or standalone algorithm capability.
Therefore, the requested information regarding acceptance criteria and studies for an AI/ML device, such as those related to:
- A table of acceptance criteria and reported device performance (in the context of AI metrics like sensitivity, specificity, etc.)
- Sample sizes for test sets and data provenance (for AI model evaluation)
- Number of experts and their qualifications for ground truth establishment
- Adjudication methods
- Multi-Reader Multi-Case (MRMC) comparative effectiveness studies
- Standalone algorithm performance
- Type of ground truth (for AI diagnosis/detection)
- Training set sample size and ground truth establishment
cannot be extracted from this document because it describes a Class I medical device (surgical gloves) which undergoes physical, chemical, and biocompatibility testing, not AI/ML model validation.
However, I can extract the acceptance criteria and performance data relevant to this specific device (surgical gloves) as presented in the document:
The document focuses on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device (K983489, Encore Mark IV Powder Free Surgical Gloves). Substantial equivalence is shown through various performance tests against established ASTM and ISO standards.
Acceptance Criteria and Reported Device Performance (for Surgical Gloves):
Here's a table summarizing the acceptance criteria (standards/minimums) and the performance of the "Subject Glove" (ENCORE® Latex Textured Surgical Gloves) as reported in the "Technological Comparison Table" and "Chemotherapy Drug Permeation" section:
| Characteristic | Acceptance Criteria (Standard/Minimum) | Reported Device Performance (Subject Glove K202765) |
|---|---|---|
| Freedom from holes | ASTM D3577, ASTM D5151; G-I, AQL 1.5 | Meets ASTM D3577; Meets ASTM D5151 |
| Length (various sizes) | ASTM D3577; e.g., 5.5: 245 min mm; 9.0: 265 min mm | Min. 295 mm (for 5.5, 7.0, 9.0), Min. 296 mm (for 6.5, 7.5, 8.0), Min. 297 mm (for 8.5) (All meet/exceed min) |
| Thickness (cuff, palm, finger) | ASTM D3577; 0.10 min mm | Cuff: min. 0.158 mm; Palm: min. 0.220 mm; Finger: min. 0.225 mm (All meet/exceed min) |
| Width (various sizes) | ASTM D3577; e.g., 5.5: 70 ± 6 mm; 9.0: 114 ± 6 mm | 73-75 mm (5.5); 78-79 mm (6.0); 83-84 mm (6.5); 90-91 mm (7.0); 96-97 mm (7.5); 102-103 mm (8.0); 107-109 mm (8.5); 114-115 mm (9.0) (All meet criteria) |
| Physical Properties (Before Ageing) | ASTM D3577; Tensile Strength: Min. 24 Mpa; Ultimate Elongation: Min. 750%; Stress at 500% Elongation: Max. 5.5 | Tensile Strength: min. 24 Mpa; Ultimate Elongation: min. 780%; Stress at 500% Elongation: max. 2.0 (All meet/exceed criteria) |
| Physical Properties (After Ageing) | ASTM D3577; Tensile Strength: Min. 18 Mpa; Ultimate Elongation: Min. 560% | Tensile Strength: min. 20 Mpa; Ultimate Elongation: min. 880% (All meet/exceed criteria) |
| Powder Content | ASTM D3577, ASTM D6124; Max. 2 mg/glove | Max. 0.57 mg/glove (Meets criteria) |
| Biocompatibility (Primary Skin Irritation) | ISO 10993-10; No Animal Irritation | Did not cause an irritant response |
| Biocompatibility (Dermal Sensitization) | ISO 10993-10; No Animal Irritation | Did not produce a skin sensitization effect |
| Biocompatibility (In vitro Cytotoxicity) | ISO 10993-5; (General expectation of non-cytotoxicity at relevant dilutions) | Cytotoxic (grade 4) at undiluted, 1:2, 1:4, 1:8 dilutions; Non-cytotoxic, grade 2 at 1:16 dilution, grade 0 at 1:32 and 1:64 dilutions |
| Biocompatibility (Acute Systemic Toxicity) | ISO 10993-11; No Systemic Toxicity | Did not reveal systemic toxicity |
| Protein Label Claim | 50 micrograms or less of total water extractable protein per gram | Contains 50 micrograms or less of total water extractable protein per gram |
| Chemotherapy Drugs Permeation (Individual Drugs) | ASTM D6978 (Specific breakthrough times vary; ">240 min" implies satisfactory resistance) | Fluorouracil, Etoposide, Cyclophosphamide, Paclitaxel, Doxorubicin Hydrochloride, Methotrexate, Vincristine Sulfate: >240 minutes breakthrough |
| Carmustine: 13.2 minutes breakthrough (Warning: Do not use Carmustine) | ||
| Thiotepa: 12.0 minutes breakthrough (Warning: Do not use Thiotepa) | ||
| Non-Pyrogenic Claim | ISO 10993-12 (implies meeting non-pyrogenic standards) | Non-Pyrogenic |
| Color, Pigment, Intended Use | Same as predicate device (no specific quantitative criteria) | Natural, Titanium Dioxide, Same intended use |
Additional Information from the document:
- Sample sizes used for the test set and the data provenance: The document does not specify exact sample sizes for each test (e.g., how many gloves were tested for holes, dimensions, etc.), only that tests were conducted according to specified ASTM and ISO standards. The data provenance is from non-clinical testing conducted by the manufacturer (Careplus (M) SDN BHD) in Malaysia. The tests are prospective in the sense that they are performed on the device to demonstrate compliance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are physical/chemical tests on a medical device, not a diagnosis or detection task requiring expert consensus on ground truth.
- Adjudication method: Not applicable for these types of tests.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable. This is for AI/ML diagnostic devices, not surgical gloves.
- Standalone (i.e. algorithm only without human-in-the-loop performance): Not applicable. This is for AI/ML devices.
- The type of ground truth used: The ground truth for this device's performance is established by objective measurements against defined international standards (ASTM, ISO) for physical properties (e.g., dimensions, tensile strength), chemical properties (e.g., powder content, protein content, chemotherapy permeation), and biological safety (biocompatibility tests).
- The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
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