(104 days)
Not Found
No
The device is a standard patient examination glove and the description contains no mention of AI or ML technology.
No.
The device is a patient examination glove, intended to prevent contamination between patient and examiner, not to treat a disease or condition.
No
Explanation: The device is a patient examination glove, intended to prevent contamination between patient and examiner. It does not collect or analyze any physiological data to diagnose a condition.
No
The device is a physical glove made of Nitrile Butadiene Rubber, not software.
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 "disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device used for infection control, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description focuses on the physical characteristics and materials of the glove, consistent with a barrier device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The performance studies focus on the physical integrity and biocompatibility of the glove, not its ability to diagnose a condition.
- Predicate Device: The predicate device is also a patient examination glove, which falls under the category of medical devices used for barrier protection, not IVDs.
IVDs are devices used to perform tests on specimens (like blood, urine, tissue) to diagnose diseases or other conditions. This glove does not perform such tests.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The gloves are powder free, ambidextrous with beaded-cuff, black colored, single-use disposable devices that come in six sizes (XS, S, M, L, XL, XXL), and supplied in Non-Sterile state.
The gloves are made of Nitrile Butadiene Rubber, designed and manufactured in accordance with ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.
Its physical and performance characteristics meet all requirements of ASTM D6319-10.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner's hand
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)
Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile have been tested against the applicable ASTM standards listed above, and meet the requirements set forth in those standards.
| Characteristic | Standards Requirements | Results Summary | Conclusions |
|---|---|---|---|
| Dimensions | ASTM D6319-10 | Length >= 230mm Palm Thickness >= 0.05mm Finger Thickness >= 0.05mm Width X-Small 70-80mm Small 80-90mm Medium 90-100mm Large 101-111mm X-Large 111-121mm XX-Large 121-131mm | Meets Standard Requirements |
| Physical Properties | ASTM D6319-10 | Before Aging After Aging Tensile Strength >= 14 MPA >= 14 MPA Elongation >= 500% >= 400% | Meets Standard Requirements |
| Freedom from pinholes | ASTM D5151-11 ASTM D6319-10 | Tested in accordance with ASTM D5151 test method. Pass quality level at G1 AQL 1.5 | Meets Standard Requirements |
| Powder Free Residue | ASTM D6124-11 ASTM D6319-10 | Result generated values |
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, with three profiles overlapping to create a sense of depth and connection. The profiles are rendered in black and white. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 12, 2015
Kossan International Sdn. Bhd. Ms. Cho Sow Fong Manager Regulatory Affairs Wisma Kossan, Lot 782, Jalan Sungai Putus Off Batu 3 3/4, Jalan Kapar Klang, Selangor Darul Ehsan MALAYSIA 42100
Re: K143131
Trade/Device Name: Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile. Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: January 6, 2015 Received: January 8, 2015
Dear Ms. Fong:
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.
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Page 2 - Ms. Fong
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K143131
Device Name
Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
| 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)
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Image /page/3/Picture/0 description: The image shows the logo for KOSSAN International. The word "KOSSAN" is in large, red, bold letters. Above the "K" is a gray graphic of three curved lines. Below the word "KOSSAN" is the word "INTERNATIONAL" in smaller, gray letters.
510(k) Premarket Notification K143131
FDA 510(k), Premarket Notification: 510(k) Summary of Safety and Effectiveness Information
Date Prepared: February 10, 2015
- 1.0 Submitter:
Kossan International Sdn. Bhd. Wisma Kossan, Lot 782, Jalan Sungai Putus, Off Batu 3 34, Jalan Kapar, 42100 Klang, Selangor, Malaysia
Telephone No.: +603 3291 0516 Fax No.: +603 3291 0542
2.0 Contact Person:
| Contact: | Ms Cho Sow Fong |
|---|---|
| Telephone No.: | +603 3291 0516 |
| Fax No. : | +603 3291 0542 |
3.0 Name of Device:
| Trade Name(s) | : Powder Free Nitrile Patient Examination Glove
Black Colored, Non-Sterile. |
|-----------------------|--------------------------------------------------------------------------------|
| Common Name | : Powder-Free Nitrile Patient Examination Glove |
| Classification Name | : Patient Examination Glove |
| Regulation Number | : 21 CFR 880.6250 |
| Classification Number | : Class I |
| Product Code | : 80 LZA |
4.0 Identification of the Legally Marketed Device:
Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile, Class I Patient Examination Gloves, Nitrile - 80 LZA, meets all of the requirements of ASTM D 6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application.
Predicate Device 1: K121529, Black Powder Free Nitrile Patient Exam Glove.
There are no different technological characteristics compared to the Predicate Devices.
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Image /page/4/Picture/1 description: The image shows the logo for KOSSAN International. The word "KOSSAN" is in large, red, bold letters. Above the "K" is a gray design of three curved lines. Below the word "KOSSAN" is the word "INTERNATIONAL" in smaller, gray letters.
510(k) Premarket Notification K143131
5.0 Description of Device:
Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The gloves are powder free, ambidextrous with beaded-cuff, black colored, single-use disposable devices that come in six sizes (XS, S, M, L, XL, XXL), and supplied in Non-Sterile state.
The gloves are made of Nitrile Butadiene Rubber, designed and manufactured in accordance with ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.
Its physical and performance characteristics meet all requirements of ASTM D6319-10.
6.0 Indications for Use:
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
7.0 Summary of the Technological Characteristics of the Device:
Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile processes the following technological characteristic (as compared to ASTM or equivalent standards):
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Image /page/5/Picture/0 description: The image contains the logo for KOSSAN International. The logo features a stylized letter 'K' with a red color scheme, accompanied by the text 'KOSSAN' in bold, red letters. Below the main text, the word 'INTERNATIONAL' is written in a smaller, gray font.
510(k) Premarket Notification K143131
| Characteristic | Standards
Requirements | Results Summary | Conclusions | | | | | | | | | |
|--------------------------|----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|--|--|--|--|--|--|--|--|-----------------------------------|
| Dimensions | ASTM D6319-10 | Length $\ge$ 230mm
Palm Thickness $\ge$ 0.05mm
Finger Thickness $\ge$ 0.05mm
Width
X-Small 70-80mm
Small 80-90mm
Medium 90-100mm
Large 101-111mm
X-Large 111-121mm
XX-Large 121-131mm | Meets
Standard
Requirements | | | | | | | | | |
| Physical
Properties | ASTM D6319-10 | Before Aging After Aging Tensile Strength $\ge$ 14 MPA $\ge$ 14 MPA Elongation $\ge$ 500% $\ge$ 400% | | | | | | | | | | Meets
Standard
Requirements |
| Freedom from
pinholes | ASTM D5151-11
ASTM D6319-10 | Tested in accordance with ASTM D5151 test
method. Pass quality level at G1 AQL 1.5 | Meets
Standard
Requirements | | | | | | | | | |
| Powder Free
Residue | ASTM D6124-11
ASTM D6319-10 | Result generated values $\le$ 2 mg of residual powder
per glove. | Meets
Standard
Requirements | | | | | | | | | |
| Biocompatibility | Dermal Sensitization
(as ISO 10993-
10:2010)
Primary Skin Irritation
Test (as ISO 10993-
10:2010) | Magnusson &Kligman Scale is '0'.
Under the conditions of the study, the device is not a
sensitizer.
Primary Irritation Index for Erythema and Edema
is '0'.
Under the conditions of the study, the device is not
an irritant. | Meets
Standard
Requirements | | | | | | | | | |
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Image /page/6/Picture/1 description: The image shows the logo for KOSSAN International. The word "KOSSAN" is in large, red, bold letters. Above the word is a gray graphic of three curved lines. Below the word "KOSSAN" is the word "INTERNATIONAL" in smaller, gray letters.
510(k) Premarket Notification K143131
8.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data
Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile have been tested against the applicable ASTM standards listed above, and meet the requirements set forth in those standards.
There is no difference between the Subject Device and the Predicate Device with respect to performance standard and technological characteristics.
9.0 Substantial Equivalent Based on Assessment of Clinical Performance Data
Clinical data was not needed.
10.0 Conclusion
The Substantial Equivalent Comparison Table below outlines the similarity, and/or differences between the subject device and the predicate device for the substantial equivalent determination.
As such, this device is substantially equivalent to predicate device.
It can be concluded that the Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile, is substantially equivalent to the predicate device identified in this 510(k) summary.
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Image /page/7/Picture/0 description: The image shows the logo for Kossan International SDN. BHD. The logo features the word "KOSSAN" in red, with the word "INTERNATIONAL" in gray underneath. The company's registration number, (273178-M), is included to the right of the company name.
Substantial Equivalent Comparison Table
| Characteristics | Subject Device | Predicate Device | Comments |
|---|---|---|---|
| Identification | K143131 | ||
| Powder Free Nitrile Patient Examination | |||
| Glove, Black Colored, Non-Sterile | K121529 | ||
| Black Powder Free Nitrile Exam Glove | N/A | ||
| Device Classification Name/ | |||
| Regulation Number | Patient Examination Glove/ | ||
| 21 CFR Part 880.6250 | Patient Examination Glove/ | ||
| 21 CFR Part 880.6250 | Substantially Equivalent | ||
| Product Code | 80 LZA | 80 LZA | Substantially Equivalent |
| Intended Use | Intended for medical and dental purposes | ||
| that is worn on the examiner's hand to | |||
| prevent contamination between patient and | |||
| examiner. | Intended for medical and dental purposes | ||
| that is worn on the examiner's hand to | |||
| prevent contamination between patient and | |||
| examiner. | Substantially Equivalent | ||
| Indications for Use | A patient examination glove is a disposable | ||
| device intended for medical purposes that is | |||
| worn on the examiner's hand to prevent | |||
| contamination | |||
| between | |||
| patient | |||
| and | |||
| examiner. | The 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. | Substantially Equivalent | ||
| Materials | Nitrile | Nitrile | Substantially Equivalent |
| Color | Black | Black | Substantially Equivalent |
| Design | Ambidextrous, in different sizes per ASTM | ||
| D6319 dimension requirement. | Ambidextrous, in different sizes per ASTM | ||
| D6319 dimension requirement. | Substantially Equivalent | ||
| Performance | |||
| I. Sterility | |||
| II. Freedom from holes | |||
| III. Dimension | |||
| IV. Physical Properties | |||
| V. Powder Free Residue | Not Applicable (Non-Sterile) | ||
| Passes at AQL 1.5 | |||
| Meets ASTM D6319 | |||
| Meets ASTM D6319 | |||
| Meets ≤ 2 mg/glove | Not Applicable (Non-Sterile) | ||
| Passes at AQL 1.5 | |||
| Meets ASTM D6319 | |||
| Meets ASTM D6319 | |||
| Meets ≤ 2 mg/glove | Substantially Equivalent | ||
| Substantially Equivalent | |||
| Substantially Equivalent | |||
| Substantially Equivalent | |||
| Substantially Equivalent |
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Image /page/8/Picture/0 description: The image shows the logo for Kossan International SDN. BHD. The logo features the word "KOSSAN" in red, with the word "INTERNATIONAL" in gray underneath. The company's registration number, (273178-M), is also included in the logo. The logo is simple and professional, and it is likely used on the company's website, marketing materials, and other official documents.
| Characteristics | Subject Device | Predicate Device | Comments |
|---|---|---|---|
| Single Use | Yes | Yes | Substantially Equivalent |
| Biocompatibility Test | Under the conditions of the study, the | ||
| device is not a sensitizer or an irritant. | Passes | ||
| i. Primary Skin Irritation Test - | |||
| Gloves are non-irritating | |||
| ii. Dermal Sensitization Test - | |||
| Gloves do not display any potential for | |||
| sensitization | Substantially Equivalent | ||
| Packaging | Packed in Dispenser Boxes | Packed in Dispenser Boxes | Substantially Equivalent |
| Labeling Features | - Non-sterile |
- Powder Free
- Examination Gloves
- Ambidextrous, by Size
- Single Use Only
- Device Color: Black
- Manufactured for:
- Lot Number:
- Quantity by Weight
- Made in Malaysia | - Non-sterile
- Powder Free
- Examination Gloves
- Ambidextrous, by Size
- Single Use Only
- Device Color: Black
- Manufactured for:
- Lot Number:
- Quantity by Weight
- Made in Malaysia | Substantially Equivalent |