(252 days)
Not Found
Not Found
No
The 510(k) summary describes a physical medical device (surgical gloves) and its performance against chemotherapy drugs. There is no mention of software, algorithms, or any technology that would incorporate AI or ML.
No
The device is described as a "surgeon's glove" intended as a "barrier for protection against cross-contamination," not for treating a disease or condition.
No
This device is a surgeon's glove, intended to be worn for protection as a barrier. It does not diagnose any condition or disease.
No
The device described is a physical medical device (surgical gloves) and does not involve any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "barrier for protection against cross-contamination between the healthcare personnel and patient." This describes a physical barrier device used during medical procedures.
- IVD Definition: An In Vitro Diagnostic device is used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This glove does not perform any such analysis on biological specimens.
- Performance Testing: The performance testing described relates to the glove's ability to resist permeation by chemotherapy drugs, which is a measure of its barrier function, not its diagnostic capability.
Therefore, this device falls under the category of a medical device, specifically a surgical glove, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn on the hands of healthcare personnel as a barrier for protection against cross-contamination between the healthcare personnel and patient.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| Chemotherapy Drug | Concentration | Average Breakthrough Detection Time (Minutes) |
|---|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 27.3 | |
| Cisplatin (1.0 mg/ml) | > 240 | |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | > 240 | |
| Dacarbazine (10.0 mg/ml) | > 240 | |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 | |
| Etoposide (20.0 mg/ml) | > 240 | |
| Fluorouracil (50.0 mg/ml) | > 240 | |
| Ifosfamide (50.0 mg/ml) | > 240 | |
| Methotrexate (25.0 mg/ml) | > 240 | |
| Mitomycin C (0.5 mg/ml) | > 240 | |
| Mitoxantrone (2.0 mg/ml) | > 240 舖 | |
| Paclitaxel (6.0 mg/ml) | > 240 | |
| ThioTepa (10.0 mg/ml) | 26.9 | |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |
*WARNING: Do not use Carmustine and ThioTepa.
Product codes
KGO, LZC
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & 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".
June 11, 2021
Wrp Asia Pacific Sdn Bhd % Saravanan Ramasamy Head of QA/RA Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi 43900 Sepang, Selangor Darul Ehsan Malaysia
Re: K203030
Trade/Device Name: Powder Free Nitrile Surgical Glove, Sterile, 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, LZC Dated: March 3, 2021 Received: March 17, 2021
Dear Saravanan Ramasamy:
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.
1
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 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).
Sincerelv.
Ryan Ortega -S
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
2
Indications for Use
510(k) Number (if known) K203030
Device Name
POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Indications for Use (Describe)
A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn on the hands of healthcare personnel as a barrier for protection against cross-contamination between the healthcare personnel and patient.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| Chemotherapy Drug | Concentration | Average Breakthrough Detection Time (Minutes) |
|---|---|---|
| * Carmustine (BCNU) (3.3 mg/ml) | 27.3 | |
| Cisplatin (1.0 mg/ml) | > 240 | |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | > 240 | |
| Dacarbazine (10.0 mg/ml) | > 240 | |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 | |
| Etoposide (20.0 mg/ml) | > 240 | |
| Fluorouracil (50.0 mg/ml) | > 240 | |
| Ifosfamide (50.0 mg/ml) | > 240 | |
| Methotrexate (25.0 mg/ml) | > 240 | |
| Mitomycin C (0.5 mg/ml) | > 240 | |
| Mitoxantrone (2.0 mg/ml) | > 240 | |
| Paclitaxel (6.0 mg/ml) | > 240 | |
| * ThioTepa (10.0 mg/ml) | 26.9 | |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |
*WARNING: Do not use Carmustine and ThioTepa.
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)
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