(101 days)
No
The device is a standard examination glove and the summary describes only physical and performance testing related to material properties and safety, with no mention of AI/ML or related concepts.
No
The gloves are a barrier to prevent contamination, not to treat or diagnose a medical condition.
No
The device is a patient examination glove, which is used to prevent contamination between the patient and examiner, not to diagnose a condition or disease.
No
The device is a physical examination glove, which is a hardware medical device, 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 to prevent contamination between patient and examiner by being worn on the hands or fingers. This is a physical barrier function, not a diagnostic test performed on a sample from the body.
- Device Description: The description focuses on the physical properties and standards met by the glove (ASTM D6319-10).
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on the physical integrity, biocompatibility, and freedom from defects of the glove itself, not on its ability to diagnose a condition.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This glove does not fit that description.
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 hands or fingers to prevent contamination between patient and examiner.
Product codes
LZA
Device Description
The Powder Free Nitrile Examination Gloves (Blue) meets all the requirements of ASTM Specification D6319-10 - Standard Specification for Nitrile Examination Gloves for Medical Application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands or fingers
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner's, medical purposes
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
The performance test data of non-clinical tests that support a determination of substantial equivalence is the same as described in section 6.0 above and meet ASTM standards, and FDA requirements for water leak test on pinhole AQL.
The Powder Free Nitrile Examination Gloves (Blue) are summarized with the following technological characteristics and is substantially equivalent to the predicate device with regard to physical characteristics, design, product features, and intended use. Both gloves are made with nitrile latex and meets ASTM Specification D6319-10 - Standard Specification for Nitrile Examination Gloves for Medical Application or equivalent standards.
Key Metrics
Dimensions: Meets ASTM D6319-10 Standard requirements, Minimal Value for Length: 240mm, Minimal Value for Width: 93mm
Physical Properties: Meets ASTM D6319-10 Standard requirements, Tensile Strength: Before Aging: Minimal Value: 16.20 MPa, After Accelerated Aging: Minimal Value: 16.16 MPa, Ultimate Elongation: Before Aging Minimal Value: 661%, After Aging Minimal Value: 630%
Thickness: Meets ASTM D6319-10 Standard requirements, Palm – Minimal Value: 0.06mm, Finger – Minimal Value: 0.13mm
Biocompatibility: Pass (Under the conditions of the study, the test article is a non-irritant), Pass (Under the conditions of the study, the test article is a non-sensitizer)
Freedom from Pinholes: Meets 21 CFR 800.20 and ASTM D5151-06 Standard requirements, Passes AQL 2.5
Powder Residual: Meets ASTM D6124-06 Standard requirements, Minimal Value: 0.68 mg
Predicate Device(s)
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/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 a stylized image of three human profiles facing right, arranged in a way that resembles a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 7, 2016
Nam Viet Glove Joint Stock Company Ooi Loon Seng OA Manager Hamlet 7, Phuoc Binh Commune Long Thanh District Ho Chi Minh Dong Nai Province, VN 815300
Re: K162113
Trade/Device Name: Powder Free Nitrile Examination Gloves (Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: September 26, 2016 Received: October 3, 2016
Dear Ooi Loon Seng:
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K162113 .
Device Name
Powder Free Nitrile Examination Gloves (Blue)
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
Type of Use (Select one or both, as applicable)
J Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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3
510(k) SUMMARY 510(k) Number: K162113
1.0 Submitter :
Nam Viet Glove Joint Stock Company, Hamlet 7, Phuoc Binh Commune, Long Thanh District 815300, Dong Nai Province, Vietnam.
| Phone No. : | +84 08 3514 7788 |
|---|---|
| Fax No. : | +84 08 3840 8506 |
| Contact Person : | Ooi Loon Seng (Mdm) |
| Email : | lsooi@navigloves.com |
Date of Preparation : 01 November 2016
2.0 Name of the Device
Powder Free Nitrile Examination Gloves (Blue)
| Common Name | : | Nitrile Patient Exam Gloves |
|---|---|---|
| Classification Name | : | Patient Examination Gloves (21 CFR 880.6250 |
| Product Code | : | Nitrile — LZA |
3.0 Identification of The Legally Marketed Devices That Equivalency is Claimed:
Predicate Device :
RS Safe Blue Nitrile Medical Examination Gloves Powder Free (Non-Sterile) Company : Riverstone Resources Sdn. Bhd. 510(K) : K100603 Requlatory Class I Product Code : LZA
4.0 Description of the Device:
The Powder Free Nitrile Examination Gloves (Blue) meets all the requirements of ASTM Specification D6319-10 - Standard Specification for Nitrile Examination Gloves for Medical Application.
5.0 Intended Use of the Device
The Powder Free Nitrile Examination Glove (Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
6.0 Summary of the Technological Characteristics of the Device:
The Powder Free Nitrile Examination Gloves (Blue) are summarized with the following technological characteristics and is substantially equivalent to the predicate device with regard to
4
Traditional 510(k) Premarket Notification Powder Free Nitrile Examination Gloves (Blue)
physical characteristics, design, product features, and intended use. Both gloves are made with nitrile latex and meets ASTM Specification D6319-10 - Standard Specification for Nitrile Examination Gloves for Medical Application or equivalent standards.
| CHARACTERISTICS | STANDARDS &
ACCEPTANCE CRITERIA | DEVICE PERFORMANCE |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dimensions | ASTM D6319-10:
Length:
Size XS & S - min. 220mm
Size M & L - min. 230mm | Meets ASTM D6319-10 Standard
requirements
Minimal Value for Length: 240mm |
| | Width - min. 95 $\pm$ 10mm | Minimal Value for Width: 93mm |
| Physical Properties | ASTM D6319-10:
Tensile Strength:
Before Aging: 14 MPa
After Aging: 14 MPa
Ultimate Elongation:
Before Aging: min. 500% | Meets ASTM D6319-10 Standard
requirements
Tensile Strength:
Before Aging: Minimal Value:
16.20 MPa
After Accelerated Aging:
Minimal Value: 16.16 MPa
Ultimate Elongation:
Before Aging Minimal Value: |
| | After Aging: min. 400% | 661%
After Aging Minimal Value: 630% |
| Thickness | ASTM D6319-10:
Min. 0.05mm | Meets ASTM D6319-10 Standard
requirements
Palm – Minimal Value: 0.06mm
Finger – Minimal Value: 0.13mm |
| Biocompatibility | ISO 10993-10: 2010
Biological evaluation of
medical devices - Part 10:
Tests for irritation and skin
sensitization | Pass (Under the conditions of the
study, the test article is a non-
irritant) |
| Biocompatibility | ISO 10993-10: 2010
Biological evaluation of
medical devices - Part 10:
Tests for irritation and skin
sensitization | Pass (Under the conditions of the
study, the test article is a non-
sensitizer) |
| Freedom from Pinholes | 21 CFR 800.20; ASTM
D5151-06
AQL 2.5 | Meets 21 CFR 800.20 and ASTM
D5151-06 Standard requirements
Passes AQL 2.5 |
| Powder Residual | ASTM D6124-06:
$\leq$ 2 mg / glove | Meets ASTM D6124-06 Standard
requirements
Minimal Value: 0.68 mg |
7.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data
The performance test data of non-clinical tests that support a determination of substantial equivalence is the same as described in section 6.0 above and meet ASTM standards, and FDA requirements for water leak test on pinhole AQL.
8.0 Substantial Equivalent Based on Assessment of Clinical Performance Data
5
Traditional 510(k) Premarket Notification Powder Free Nitrile Examination Gloves (Blue)
Not applicable - Clinical data is not needed for gloves or most devices cleared by the 510(k) process.
9.0 Substantial Equivalence Comparison
The Powder Free Nitrile Examination Gloves (Blue) is substantially equivalent to the predicate device with respect to intended use, product features and the technological characteristics. The substantial equivalence comparison is presented in the table below:
| Characteristic and
parameters | Riverstone Resources Sdn.
Bhd. K100603
RS Safe Blue Nitrile Medical
Examination Gloves Powder
Free (Non-Sterile)
(Predicate) | Powder Free Nitrile
Examination Gloves (Blue)
(Proposed) – K162113 | Substantial
Equivalence
(SE) |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Product Code | LZA | LZA | Same |
| Intended use | Intended for medical purposes
that is worn on the examiner's
hands or fingers to prevent
contamination between patient
and examiner. | Intended for medical purposes
that is worn on the examiner's
hands or fingers to prevent
contamination between patient
and examiner. | Same |
| Indications for Use
Statement | A powder free patient
examination gloves 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 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. | Same |
| Device Material | Nitrile Synthetic Latex | Nitrile Synthetic Latex | Same |
| Color | Blue | Blue | Same |
| Additives | No flavor additive | No flavor additive | Same |
| Instruction For Use
on Labeling | Single Use Only | Single Use Only | Same |
| Construction | Ambidextrous | Ambidextrous | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Acceptance Criteria | ASTM D6319-10 | ASTM D6319-10 | Same |
Device Tolerances & Specifications :
| Meets ASTM D6319-10 | Meets ASTM D6319-10 | Same | |
|---|---|---|---|
| Dimensions | Overall Length: | ||
| Size XS & S - min. 220mm | |||
| Size M & L - min. 230mm | Overall Length: | ||
| Size XS & S - min. 220mm | |||
| Size M & L - min. 230mm | |||
| Width (± 10mm) | |||
| Size XS - 70mm | |||
| Size S - 80mm | |||
| Size M - 95mm | |||
| Size L - 110mm | |||
| Size XL - 120mm | Width (± 10mm) | ||
| Size XS - 70mm | |||
| Size S - 80mm | |||
| Size M - 95mm | |||
| Size L - 110mm | |||
| Size XL - 120mm | |||
| Thickness at Finger - min. | |||
| 0.05mm | Thickness at Finger - min. | ||
| 0.05mm |
6
Traditional 510(k) Premarket Notification Powder Free Nitrile Examination Gloves (Blue)
| | Thickness at Palm - min.
0.05mm | Thickness at Palm - min.
0.05mm | |
|-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|------|
| | Meets ASTM D6319-10 : | Meets ASTM D6319-10 : | |
| Physical Properties | Before Aging
Tensile Strength – min. 14.0
MPa
Ultimate Elongation - min.
500% | Before Aging
Tensile Strength – min. 14.0 MPa
Ultimate Elongation - min. 500% | |
| | After Aging
Tensile Strength - min. 14.0
MPa
Ultimate Elongation - min.
400% | After Aging
Tensile Strength – min. 14.0 MPa
Ultimate Elongation - min. 400% | |
| Biocompatibility Test
a. Irritation Tests
b. Skin
Sensitization
Tests | Under the conditions of the
study, the test article is a non-
irritant and non-sensitizer. | Under the conditions of the
study, the test article is a non-
irritant and non-sensitizer. | Same |
| Residual Powder
test | Meets ASTM D6124-06: