(459 days)
A Powder Free White Sterilized Polyisoprene Surgical Gloves- Tested for Use with Chemotherapy Drugs is a disposable device intended for invasive surgery procedures that is to be worn on both the hands by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with Chemotherapy Drug as per ASTM D 6978 - Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drug.
Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs.
This document is a 510(k) clearance letter for Powder Free White Sterilized Polyisoprene Surgical Gloves. It is for a medical device and not for an AI/ML powered device, therefore no AI-specific performance criteria or studies are present.
Here's an analysis based on the provided text, focusing on the available information regarding device performance and acceptance criteria, even though it's not an AI/ML device:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for these surgical gloves relate to their resistance to permeation by chemotherapy drugs, as tested according to ASTM D 6978. The "acceptance criteria" here implicitly refers to showing sufficient resistance, often exceeding a certain time threshold, though the direct numerical acceptance threshold isn't explicitly stated but inferred from the predicate device comparisons and the nature of such testing. For chemotherapy gloves, a breakthrough time of >240 minutes is generally considered ideal for many drugs.
| Chemotherapy Drug Permeation and Concentration | Acceptance Criteria (Implicit) | Reported Device Performance (Average Breakthrough Detection Time) |
|---|---|---|
| Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) | (Likely >240 min for ideal) | 12.6 min |
| Cisplatin 1.0 mg/ml (1,000ppm) | (Likely >240 min for ideal) | >240 min |
| Cyclophosphamide (Cytoxan) 20mg/ml (20,000ppm) | (Likely >240 min for ideal) | >240 min |
| Dacarbazine (DTIC) 10.0 mg/ml (10,000ppm) | (Likely >240 min for ideal) | >240 min |
| Doxorubicin Hydrochloride 2.0 mg/ml (2,000ppm) | (Likely >240 min for ideal) | >240 min |
| Etoposide (Toposar) 20.0 mg/ml (20,000ppm) | (Likely >240 min for ideal) | >240 min |
| Fluorouracil 50.0 mg/ml (50,000ppm) | (Likely >240 min for ideal) | >240 min |
| Ifosfamide 50.0 mg/ml (50,000ppm) | (Likely >240 min for ideal) | >240 min |
| Methotrexate 25 mg/ml (25,000ppm) | (Likely >240 min for ideal) | >240 min |
| Mitomycin C 0.5 mg/ml (500ppm) | (Likely >240 min for ideal) | >240 min |
| Mitoxantrone 2.0 mg/ml (2,000ppm) | (Likely >240 min for ideal) | >240 min |
| Paclitaxel (Taxol) 6.0 mg/ml (6,000ppm) | (Likely >240 min for ideal) | >240 min |
| Thio-Tepa 10.0 mg/ml (10,000ppm) | (Likely >240 min for ideal) | 12.0 min |
| Vincristine Sulfate 1.0 mg/ml (1,000ppm) | (Likely >240 min for ideal) | >240 min |
Note: The document explicitly states: "Please Note that Carmustine and Thio-Tepa have low permeation time of less than 240 minutes." This suggests that while ideal is >240 min, the device still meets FDA requirements given its overall performance and comparison to predicate devices, and likely appropriate labeling for users about these specific drugs.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the permeation testing (i.e., how many gloves were tested for each drug). The data provenance refers to "as per ASTM D 6978 - Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drug," indicating a standardized laboratory test method. It is not patient data, so "country of origin" and "retrospective/prospective" are not applicable in the human data sense.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Not applicable. This is a physical device subject to standardized chemical permeation testing, not a diagnostic device requiring expert opinion for ground truth. The "ground truth" is established by the chemical permeation laboratory measurement according to the ASTM D 6978 standard.
4. Adjudication Method for the Test Set
Not applicable, as the "ground truth" is based on objective chemical permeation measurements rather than subjective human assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI/ML-powered diagnostic or interpretive device.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a physical device, not an algorithm.
7. Type of Ground Truth Used
The ground truth used is objective laboratory measurement of chemotherapy drug permeation, specifically the "Average Breakthrough Detection Time" determined according to ASTM D 6978 - Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drug.
8. Sample Size for the Training Set
Not applicable. This is a physical device, not an AI/ML model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
July 9, 2021
GX Corporation Sdn Bhd Khon Foo Managing Director Lot 6491 Batu 5 3/4. Sementa Jalan Kapar Klang, Selangor Darul Ehsan 42100 Malaysia
Re: K200915
Trade/Device Name: Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO Dated: March 20, 2020 Received: April 6, 2020
Dear Khon Foo:
We have reviewed vour 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.
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
{1}------------------------------------------------
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 and Part 809 ); medical device reporting (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 medical devices and radiation-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 -S
Ryan Ortega, Ph.D. 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 Quality Center for Devices and Radiological Health
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K200915
Device Name
Powder Free White Sterilized Polyisoprene Surgical Gloves - Tested for Use with The Chemotherapy Drugs.
Indications for Use (Describe)
A Powder Free White Sterilized Polyisoprene Surgical Gloves- Tested for Use with Chemotherapy Drugs is a disposable device intended for invasive surgery procedures that is to be worn on both the hands by operating room personnel to protect a surgical wound from contamination .
These gloves were tested for use with Chemotherapy Drug as per ASTM D 6978 - Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drug.
| List of tested Chemotherapy Drugs are as follows: | |
|---|---|
| Chemotherapy Drug Permeation and Concentration | Average Breaktrough Detection Time(in Minutes) |
| 1. Carmustine (BCNU)3.3 mg/ml(3,300 ppm) | 12.6 min |
| 2. Cisplatin 1.0 mg/ml (1,000ppm) | >240 min |
| 3. Cyclophosphamide (Cytoxan) 20mg/ml(20,000ppm) | >240 min |
| 4. Dacarbazine (DTIC)10.0 mg/ml(10,000ppm) | >240 min |
| 5. Doxorubicin Hydrochloride 2.0 mg/ml (2,000ppm) | >240 min |
| 6. Etoposide (Toposar) 20.0 mg/ml (20,000ppm) | >240 min |
| 7. Fluorouracil 50.0 mg/ml (50,000ppm) | >240 min |
| 8. Ifosfamide 50.0 mg/ml (50,000ppm) | >240 min |
| 9. Methotrexate 25 mg/ml (25,000ppm) | >240 min |
| 10. Mitomycin C 0.5 mg/ml (500ppm) | >240 min |
| 11. Mitoxantrone 2.0 mg/ml (2,000ppm) | >240 min |
| 12.Paclitaxel (Taxol) 6.0 mg/ml (6,000ppm) | >240 min |
| 13. Thio-Tepa 10.0 mg/ml (10,000ppm) | 12.0 min |
| 14. Vincristine Sulfate 1.0 mg/ml (1,000ppm) | >240 min |
Please Note that Carmustine and Thio-Tepa have low permeation time of less than 240 minutes.
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
{3}------------------------------------------------
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
§ 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).