(297 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of a standard examination glove, with no mention of AI or ML.
No.
The device, a patient examination glove, is intended to prevent contamination between the patient and the examiner, not to treat a disease or condition.
No
Explanation: The device description clearly states its purpose is to prevent contamination between patient and examiner. It is a physical barrier and performs no diagnostic function.
No
The device description clearly states it is a "natural rubber latex examination glove," which is a physical hardware device, not software.
No, 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 examiners hand or finger to prevent contamination between patient and the examiner." This describes a barrier device used for infection control, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical properties and material of the glove.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), reagents, or providing diagnostic information.
- Performance Studies: The performance studies focus on the physical integrity and protein content of the glove, which are relevant to its function as a barrier, not as a diagnostic tool.
IVD devices are specifically designed to perform tests on samples taken from the body to provide information about a person's health. This glove's purpose is to prevent the transfer of contaminants, which is a different function entirely.
N/A
Intended Use / Indications for Use
A Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and the examiner.
Product codes (comma separated list FDA assigned to the subject device)
LYY
Device Description
The subject device of this submission is a natural rubber latex examination glove. The glove is non-sterile and meets the recommendations of ASTM D3578-05(2015). The device is natural in color.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
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.
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
§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with a series of human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 11, 2017
UG Global Resources Sdn Bhd Kenneth Stanton President UG Healthcare (USA) Inc. 1565 Sunflower Avenue Costa Mesa, California 92626
Re: K161961
Trade/Device Name: UniTex Non-Sterile, Powder-Free, Latex Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: April 5, 2017 Received: April 7, 2017
Dear Kenneth Stanton:
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 Industry and Consumer Education 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. 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
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 Industry and Consumer Education 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.
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161961
Device Name
UniTex Non-Sterile, Powder-Free, Latex Examination Glove
Indications for Use (Describe)
A Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and the examiner.
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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SUMMARY PREMARKET 510(k) NOTIFICATION
UniTex Non-Sterile, Powder-Free, Latex Examination Glove K161961
Submission Applicant-
UG Global Resources Sdn Bhd 1st Floor No. 18 Jalan Data Abd Rahman 70000, Seremban, Negeri Sembilan, Malaysia
Official Correspondent -
Kenneth J. Stanton 1565 Sunflower Avenue Costa Mesa, Ca 92626 Tel: (714)444-2248 Fax: (714)444-2271
Date of Preparation: April 13, 2017
Trade Name: UniTex Non Sterile, Powder Free, Latex Examination Glove
Common Name: Latex Examination Gloves Classification Name: Patient Examination Glove (per 21 CFR 880.6250) Class 1: Powder-Free Latex examination glove, LYY that meets all of the requirements of ASTM D3578-05(2015).
Predicate Device: K010879.UniGlove Powder-Free Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less)
Device Description: The subject device of this submission is a natural rubber latex examination glove. The glove is non-sterile and meets the recommendations of ASTM D3578-05(2015). The device is natural in color.
Indications for Use: A 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 the patient and the examiner.
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Substantial Equivalence Table-
| | Color | Material | Biocompatibility Tests | ASTM D3578
Tensile Strength (MPa) | ASTM D3578
Elongation % |
|--------------------------------|---------|----------|----------------------------------------------------------------------------------------------------------------------|--------------------------------------|----------------------------|
| Subject
Device
K161961 | Natural | Latex | ISO 10993-10 - Primary Irritation Test- Under the
conditions of the study, the device is non-irritating | Before Aging- min 18.0 | Before Aging - min.
650 |
| | | | ISO 10993-10 - Dermal Sensitization Assay -
Under the conditions of the study, the device is a
non-sensitizer | After Aging - min 14.0 | After Aging - min.
500 |
| Predicate
Device
K010879 | Natural | Latex | ISO 10993-10 - Dermal Sensitization Assay - Under
the conditions of the study, the device is a non-
sensitizer | Before Aging- min 21.0 | Before Aging- min.
700 |
| | | | ISO 10993-10 - Primary Irritation Test- Under the
conditions of the study, the device is non-irritating | After Aging- min 16.0 | After Aging - min.
500 |
| | ASTM D3578
Dimensions | ASTM D5151
Waterleak | ASTM D5712
Protein Claim | ASTM D6124
Powder Content | | Sizes | Single Use | Indications for Use |
|--------------------------------|-------------------------------------------------------------------------------------------------------------|-------------------------|-----------------------------------------------------------------|------------------------------------|--------------------------------|-------|------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject
Device
K161961 | Palm Width - 95mm+/-10 Medium size
Length: 240mm min
Thickness; Min .08mmPalm and finger | AQL 1.5 | 50 Micrograms or less of total
water Soluble Protein per dm2 | Max 2.0mg/glove
Avg .06mg/glove | Subject
Device
K161961 | XS-XL | Yes | A 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 |
| Predicate
Device
K010879 | Palm Width- 95mm +/- 10 Medium size
Length: 240 mm min
Thickness: Min .15mm Palm and Min .17mm finger | AQL 1.5 | 50 Micrograms or less | Max 2.0mg/glove
Avg .40mg/glove | Predicate
Device
K010879 | XS-XL | Yes | A 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 |
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Comparisons- Both Kl61961 and K110879 are Chlorination Gloves. Both gloves have protein levels below the 50 Microgram per dm Threshold, both have the same specifications, both have the same AQL 1.5 for pinholes and similar powder content. Both glocomatibility tests. Additionally, both devices have similar tensile strength and elongation performance.
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| Material: | Latex | Cuff: | Beaded | Summary of Technological Characteristics: | |||
|---|---|---|---|---|---|---|---|
| Protein: | 50 Micrograms or less of total water soluble protein per dm2 | Powder Residue: | Maximum 2mg/glove | ||||
| Quality Assurance: | In compliance with ASTM D3578-05, ISO 2859-1:1999, manufactured under ISO 9001:2008, ISO | ||||||
| 13485:2003 | and | EN | ISO | 13485:2012 |
Inspection Parameters:
| Criteria | Inspection Level | AQL |
|---|---|---|
| Dimensions | S-2 | 4.0 |
| Physical Properties | S-2 | 4.0 |
| Water Tight Test 1000ml | G-1 | 1.5 |
| Visual Major Defects | G-1 | 1.5 |
| Visual Minor Defects | G-1 | 2.5 |
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Physical Properties: Dimensions: Overall Length: 240 mm minimum Width: Thickness: 95 mm minimum (for medium glove) 0.08 mm minimum BEFORE AGING Tensile Strength: 18.0 Mpa minimum Ultimate Elongation: 650% minimum
AFTER AGING 14.0 Mpa minimum 500% minimum
Special Properties: None
Packaging: 100 gloves per dispenser box, 10 boxes per case, 1,000 gloves per case
Sizes: XS-XL
Conclusion: The UniTex Non-Sterile, Powder-Free, Latex Examination Glove meets the physical property requirements of ASTM D3578-05(2015), the FDA 1000 ml water test both before and after aging, and the Protein Labeling Claim Level at 50 Micrograms or less of total water soluble protein per dm² controlled during routine production as per ASTM 5712-15. This product is as safe, as effective, and performs as well or better than the legally marketed device cleared under 510(k) # K010879.