(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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 27, 2021
Careplus (M) SDN BHD Lim Shyan CEO/Managing Director Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate Seremban, Negeri Sembilan 70450 Malaysia
Re: K202765
Trade/Device Name: ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO Dated: April 13, 2021 Received: April 16, 2021
Dear Lim Shyan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Ryan Ortega, PhD Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202765
Device Name
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
Indications for Use (Describe)
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"
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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K202765
1.0
510(K) SUMMARY
- CAREPLUS (M) SDN BHD Applicant: Address: Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan Darul Khusus, Malaysia. Phone No. 60-6-6772781 Fax No. 60-6-6772780 Contact Person Lim Kwee Shyan 2.0 Date of Summary 11th May, 2021 3.0 Device Information ENCORE® Latex Textured Surgical Gloves, Powder free with Protein Content Device Name: Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs, Non-Pyrogenic Common Name: Surgical Gloves Product Code: KGO Subsequent Product Code: LZC Classification Name: Surgeon's Gloves
4.0 Device Description
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:
Patient Examination Gloves Specialty (21 CFR 88.6250, LZC)
| 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 |
5.0 Predicate Device
K983489, Encore Mark IV Powder Free Surgical Gloves (Protein Labeling Claim), Ansell Perry. The device is a class I, Surgeon's Gloves, KGO, LZC powder-free..
6.0 Indication for Use
Powder Free Surgical gloves are sterile disposable devices intended to be worn by operating room personnel to protect aa surgical wound from contamination.
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7.0 Technological Comparison Table:
| 7.0 Technological Comparison Table: | |||||
|---|---|---|---|---|---|
| Characteristics | ASTM Specification | Standard References | Subject Glove K202765(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) | Predicate Device (Encore Mark IV Powder Free Surgical Gloves, Protein Labeling Claim, K983489) | Discussion |
| Freedom from holes | ASTM D3577ASTM D5151 | G-I, AQL 1.5 | Meets ASTM D3577Meets ASTM D5151 | Meets ASTM D3577Meets ASTM D5151 | Same |
| Dimension | ASTM D3577 | Same | |||
| Length (size: 5.5), mm | 245 min | min. 295 | Meet 245mm min | ||
| Length (size: 6.0), mm | 265 min | min. 295 | Meet 265mm min | ||
| Length (size: 6.5), mm | 265 min | min. 296 | Meet 265mm min | ||
| Length (size: 7.0), mm | 265 min | min. 295 | Meet 265mm min | ||
| Length (size: 7.5), mm | 265 min | min. 296 | Meet 265mm min | ||
| Length (size: 8.0), mm | 265 min | min. 296 | Meet 265mm min | ||
| Length (size: 8.5), mm | 265 min | min. 297 | Meet 265mm min | ||
| Length (size: 9.0), mm | 265 min | min. 295 | Meet 265mm min | ||
| Thickness (cuff), mm | 0.10 min | min. 0.158 | Meet 0.10mm min | ||
| Thickness (palm), mm | 0.10 min | min. 0.220 | Meet 0.10mm min | ||
| Thickness (finger), mm | 0.10 min | min. 0.225 | Meet 0.10mm min | ||
| Width (size: 5.5), mm | 70 ± 6 | 73-75 mm | Meet 70 ± 6 mm | ||
| Width (size: 6.0), mm | 76 ± 6 | 78-79 mm | Meet 76 ± 6 mm | ||
| Width (size: 6.5), mm | 83 ± 6 | 83-84 mm | Meet 83 ± 6 mm | ||
| Width (size: 7.0), mm | 89 ± 6 | 90-91 mm | Meet 89 ± 6 mm | ||
| Width (size: 7.5), mm | 95 ± 6 | 96-97 mm | Meet 95 ± 6 mm | ||
| Width (size: 8.0), mm | 102 ± 6 | 102-103 mm | Meet 102 ± 6 mm | ||
| Width (size: 8.5), mm | 108 ± 6 | 107-109 mm | Meet 108 ± 6 mm | ||
| Width (size: 9.0), mm | 114 ± 6 | 114-115 mm | Meet 114 ± 6 mm | ||
| Physical Properties(Before Ageing)i) Tensile Strength (Mpa)ii) Ultimate Elongation (%)iii) Stress at 500% Elongation(After Ageing)i) Tensile Strength (Mpa)ii) Ultimate Elongation (%) | ASTM D3577 | Min. 24Min. 750Max. 5.5Min. 18Min. 560 | min. 24min. 780max. 2.0min. 20min. 880 | Meets ASTM D3577 | Same |
| Powder Content | ASTM D3577ASTM D6124 | Max. 2 mg/glove | Max. 0.57 mg/glove | Meets ASTM D3577Meets ASTM D6124 | Same |
| K202765 | |||||
| Biocompatibility Testi) Primary Skin IrritationTest | ISO 10993-10 | No AnimalIrritation | Conclusion: Under theconditions of this study,the test material did notcause and irritantresponse. | Conclusion: Under theconditions of this study,the test material did notcause and irritantresponse. | Same |
| ii) Dermal SensitizationTest | ISO 10993-10 | No AnimalIrritation | Conclusion: Under theconditions of this study,the test material did notproduce a skinsensitization effect. | Conclusion: Under theconditions of this study,the test material did notproduce a skinsensitization effect. | Same |
| iii) In vitro Cytotoxicity Test | ISO 10993-5 | Conclusions: Under theconditions of this study,the test material iscytotoxic (grade 4) atundiluted, 1:2, 1:4, 1:8dilutions; andNon-cytotoxic, grade 2at 1:16 dilution, grade 0at 1:32 and 1:64dilutions | iii) No data available | Different | |
| iv) Acute Systemic Toxicity | ISO 10993-11 | Conclusion: Under theconditions of this study,the test material bothinner and outer surfacedid not reveal systemictoxicity. | iv) No data available | Different | |
| Protein Label Claim | Contains 50micrograms or less oftotal water extractableprotein per gram. | Contains 50micrograms or less oftotal water extractableprotein per gram. | Same | ||
| Chemo Drugs Claim | ASTM D6978 | - | Chemo Claim | No Chemo Claim | Different |
| Non- Pyrogenic Claim | ISO 10993-12 | - | Non-Pyrogenic | No Non-Pyrogenicclaim | Different |
| Color | - | Natural | Natural | Same | |
| White Pigment | - | Titanium Dioxide | Titanium Dioxide | Same | |
| Intended Use | - | Powder Free Surgicalgloves are steriledisposable devicesintended to be worn byoperating roompersonnel to protect asurgical wound fromcontamination. | Powder Free Surgicalgloves are steriledisposable devicesintended to be worn byoperating roompersonnel to protect asurgical wound fromcontamination. | Same |
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| Chemotherapy Drug | ASTM D6978-05 | Subject Glove(ENCORE® Latex Textured Surgical Gloves, Powder free withProtein Content Labeling Claim (50 micrograms or less) and Testedfor use with Chemotherapy drugs, Non-Pyrogenic) |
|---|---|---|
| Test ChemotherapyDrug | Concentration | Minimum Breakthrough Detection Time (min) |
| Fluorouracil (Adrucil) | 50.0mg/ml | > 240 |
| Etoposide (Toposar) | 20.0mg/ml | > 240 |
| Cyclophosphamide(Cytoxan) | 20.0mg/ml | > 240 |
| *Carmustine (BCNU) | 3.3mg/ml | 13.2 |
| *Thiotepa | 10.0mg/ml | 12.0 |
| Paclitaxel (Taxol) | 6.0mg/ml | > 240 |
| DoxorubicinHydrochloride | 2.0mg/ml | > 240 |
| Methotrexate | 25.0mg/ml | > 240 |
| Vincristine Sulfate | 1.0mg/ml | > 240 |
8.0 Summary of Non-Clinical Testing
The performance test data of the non-clinical test that support a determination of substantial equivalence are the same as mentioned immediately above (ASTM requirement).
Following standards were used for the testing:
- ASTM D3577-09 Standard Specification for Rubber Surgical Gloves
- ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves
- ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D5712-15 Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method
- ASTM D7160-16 Standard Practice for Determination of Expiration Dating for Medical Gloves
- ASTM D6978-16 Standard Assessment of Resistance of Medical Devices to Permeation
- ISO 11137-2:2013 Sterilization of Healthcare Products- Establishing the sterilization dose
9.0 Summary of Clinical Testing
Clinical data is not needed for medical gloves or of most devices cleared by the 510(k) process.
- 10.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices.
§ 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).