(45 days)
Not Found
Not Found
No
The device is a medical glove and the summary describes standard testing for chemical permeation, not AI/ML capabilities.
No
The device is described as a "powder-free patient examination glove" intended to "prevent contamination between patient and examiner," and "tested for use with chemotherapy drugs." These uses are preventative or protective, not therapeutic.
No
Explanation: The device is a glove, and its purpose is to prevent contamination and protect the examiner, not to diagnose any condition.
No
The device is a physical product (gloves) and the description focuses on material properties and performance testing related to chemical permeation, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This includes tests performed on blood, urine, tissue, etc.
- Device Function: The described device is a patient examination glove. Its primary function is a physical barrier to prevent contamination between a patient and an examiner.
- Intended Use: The intended use clearly states it's "worn on the examiner's hand or finger to prevent contamination." This is a barrier function, not a diagnostic test performed on a specimen.
- Testing for Chemotherapy Drugs: While the gloves are tested for permeation by chemotherapy drugs, this testing relates to the performance and safety of the glove as a barrier when handling these substances. It's not a test performed on a patient specimen to diagnose or monitor a condition.
The information provided describes a Class I or Class II medical device (depending on the specific classification) that serves as a physical barrier, not a diagnostic tool.
N/A
Intended Use / Indications for Use
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05. Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| No. | Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (Minutes) |
|---|---|---|
| l | Carboplatin ( 10.0 mg/ml) | >240 |
| 2 | Carmustine (BCNU) (3.3 mg/ml) | 3.0 |
| 3 | Cisplatin (1.0 mg/ml) | >240 |
| 4 | Cyclophosphamide (Cytoxan) (20.0 mg/ml). | >240 |
| 5 | Cytarabine (100.0 mg/ml) | >240 |
| б | Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
| 7 | Docetaxel (10.0 mg/ml) | >240 |
| 8 | Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| ਰੇ | Etoposide (Toposar) (20.0 mg/ml) | >240 |
| 10 | Fluorouracil (50.0 mg/ml) | >240 |
| l I | Mechlorethamine HCI (1.0 mg/ml) | >240 |
| 12 | Methotrexate (25.0 mg/ml) | >240 |
| 13 | Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| 14 | Thiotepa (10.0 mg/ml) | 75.0 |
Please note that the following drugs have extremely low permeation time: Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 3.0 minute and Thiotepa (10.0 mg/ml) has a minimum breakthrough time of 75.0 minute.
Product codes
LZA, LZC
Device Description
Not Found
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
Not Found
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 21, 2013
Ms. Noorzaliza Ahmad Quality Assurance Executive HL Rubber Industries Sdn Bhd Lot 10, Kawasan Perindustrian Dioh Kuala Pilah Negeri Sembilan, Malaysia 72000
Re: K130038
Trade/Device Name: Powder-Free Nitrile Examination Gloves, Blue, Tested for Use With Chemotherapy Drugs
Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: January 7, 2013 Received: January 29, 2013
Dear Ms. Ahmad:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Image /page/1/Picture/7 description: The image contains a stylized drawing with text and geometric shapes. The text appears to be a signature or inscription, with some words more legible than others. The geometric shapes include a series of stacked lines forming a triangular or mountain-like structure on the right side of the image. The overall style is abstract and appears to be hand-drawn.
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and . Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K130038
Device Name: Powder-Free Nitrile Examination Gloves, Blue, Tested for Use With Chemotherapy Drugs
Indications For Use: A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05. Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| No. | Chemotherapy Drug and Concentration | Minimum Breakthrough
Detection Time
(Minutes) |
|-----|------------------------------------------|-----------------------------------------------------|
| l | Carboplatin ( 10.0 mg/ml) | >240 |
| 2 | Carmustine (BCNU) (3.3 mg/ml) | 3.0 |
| 3 | Cisplatin (1.0 mg/ml) | >240 |
| 4 | Cyclophosphamide (Cytoxan) (20.0 mg/ml). | >240 |
| 5 | Cytarabine (100.0 mg/ml) | >240 |
| б | Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
| 7 | Docetaxel (10.0 mg/ml) | >240 |
| 8 | Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| ਰੇ | Etoposide (Toposar) (20.0 mg/ml) | >240 |
| 10 | Fluorouracil (50.0 mg/ml) | >240 |
| l I | Mechlorethamine HCI (1.0 mg/ml) | >240 |
| 12 | Methotrexate (25.0 mg/ml) | >240 |
| 13 | Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| 14 | Thiotepa (10.0 mg/ml) | 75.0 |
Please note that the following drugs have extremely low permeation time: Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 3.0 minute and Thiotepa (10.0 mg/ml) has a minimum breakthrough time of 75.0 minute.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ √ (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
| Elizabeth Laverie | |
|---|---|
| 2013.02.20 18:21:46 -05'00' |
Concurrence of CDRH, Office of Device Evaluation (ODE)(Division Sign-Off) Division Sign-Off)
Division of Anesthestology, General Hospital Infection Control, Dental Devices
| S10(k) Number: | K130038 |
|---|---|
| ---------------- | --------- |