(146 days)
Not Found
No
The document describes standard surgical gloves and their performance against chemotherapy drugs, with no mention of AI or ML technology.
No
The device, surgical gloves, is intended to protect healthcare personnel and prevent contamination of a surgical wound, not to treat or diagnose a disease or condition in a patient.
No
Explanation: The device is described as powder-free surgical gloves, which are protective barriers used by operating room personnel. Its intended use is to protect a surgical wound from contamination and to protect against permeation by chemotherapy drugs. It does not perform any diagnostic function.
No
The device is a physical product (surgical gloves) and the summary describes physical properties and performance testing, not software functionality.
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 "to be worn by operating room personnel to protect a surgical wound from contamination." This is a protective barrier function, not a diagnostic function.
- Device Description: The device is described as "powder-free variation of the class I sterile latex surgical gloves." This is a physical barrier device.
- Performance Studies: The performance studies focus on physical properties, biocompatibility, and resistance to chemotherapy drugs. These are all related to the protective function of the glove, not to diagnosing a condition or analyzing a sample from the human body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis, monitoring, or treatment decisions based on in vitro analysis.
The testing for chemotherapy drug permeation is a safety feature related to the intended use of protecting the wearer and the surgical wound, not a diagnostic test.
N/A
Intended Use / Indications for Use
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.
"WARNING: Do not use with Carmustine and Thiotepa"
Product codes (comma separated list FDA assigned to the subject device)
KGO, LZC
Device Description
It is the powder-free variation of the class I sterile latex surgical gloves made on-line by surface treatment on the outside and polymer coating on inner surface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating room 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)
The non-clinical performance test data demonstrate that the subject devices met the acceptance criteria or the specification for the test methodology or standard shown below.
ENCORE® Latex Acclaim, Powder free Latex Surgical Gloves with Protein Content Labeling Claim (
§ 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 contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 3, 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: K210724
Trade/Device Name: ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) 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, LZC Dated: June 22, 2021 Received: June 28, 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
1
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 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).
Sincerely.
Clarence W. Murray III -S
Clarence W. Murray, III, PhD 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
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below
510(k) Number (if known) K210724
Device Name
ENCORE® Latex Acclaim, Powder free Latex Surgical Gloves with Protein Content Labeling Claim (240 |
| Etoposide (20.0mg/ml) | >240 |
| Cyclophosphamide (20.0mg/ml) | >240 |
| Carmustine (3.3mg/ml) | 14.1 |
| Thiotepa (10.0mg/ml) | 16.9 |
| 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 with Carmustine and Thiotepa"
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below
510(k) Number (if known) K210724
Device Name
GAMMEX® Latex Standard, Powder free Latex Surgical Gloves with Protein Labeling Claim (240 |
| Etoposide (20.0mg/ml) | >240 |
| Cyclophosphamide (20.0mg/ml) | >240 |
| Carmustine (3.3mg/ml) | 14.1 |
| Thiotepa (10.0mg/ml) | 16.9 |
| 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 with 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
4
K210724
510(K) SUMMARY
- 1.0 Applicant: CAREPLUS (M) SDN BHD
- Lot 120 & 121 , Jalan Senawang 3, Address: 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 31st July, 2021
3.0 Device Information
Device Name: Surgeons Glove, Latex Powder Free with Protein Content Labeling Claim ( GAMMEX® Latex Standard. Powder free Latex Surgical Gloves with Protein Content Labeling Claim ( 240 |
| Etoposide | 20.0mg/ml | > 240 |
| Cyclophosphamide
(Cytoxan) | 20.0mg/ml | > 240 |
| *Carmustine (BCNU) | 3.3mg/ml | 14.1 |
| *Thiotepa | 10.0mg/ml | 16.9 |
| Paclitaxel | 6.0mg/ml | > 240 |
| Doxorubicin
Hydrochloride | 2.0mg/ml | > 240 |
| Methotrexate | 25.0mg/ml | > 240 |
| Vincristine Sulfate | 1.0mg/ml | > 240 |
| Warning Statement | | *Warning: Do not use with Carmustine and ThioTepa" |
Summary of Non-Clinical Testing 8.0
The non-clinical performance test data demonstrate that the subject devices met the acceptance criteria or the specification for the test methodology or standard shown below.
ENCORE® Latex Acclaim, Powder free Latex Surgical Gloves with Protein Content Labeling Claim (