(217 days)
Not Found
No
The device description and performance studies focus on the physical properties and performance of examination gloves, with no mention of AI or ML.
No
The device is a patient examination glove, intended to prevent contamination. It does not treat or diagnose a disease or condition, which are characteristic functions of a therapeutic device.
No
This device, HG PRO® Nitrile Powder Free Examination Gloves, is described as a "patient examination glove" intended to "prevent contamination between patient and examiner." Its function is protective, not diagnostic. There are no mentions of it being used to detect, diagnose, or monitor diseases or conditions.
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 clearly states the device is 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 protection, 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 material, specifications (ASTM standards), and physical characteristics of the glove. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring analytes
The device is a Class 1 medical device intended for barrier protection during patient examinations.
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
HG PRO® Nitrile Powder Free Examination Gloves are substantially equivalent to the Class 1 patient examination gloves bearing the product code Nitrile - LZA (21CFR 880.6250). They meet all the current specifications listed under the ASTM Specification D 6319 -10, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.
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 (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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned in the previous section (ASTM Requirements). No Clinical testing was required to determine substantial equivalence of this device.
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.
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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 representation of a human figure, with three overlapping profiles suggesting a sense of community and support. The profiles are connected to three flowing ribbons. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 4, 2016
Healthy Glove Co., Ltd. Teoh Shee Managing Director 119 Kanchanavanich Road, Tambol Patong Hat Yai, Songkhla 90230 THIALAND
Re: K152479
Trade/Device Name: HG PRO® Nitrile Powder Free Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: January 15, 2016 Received: March 7, 2016
Dear Mr. Shee:
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 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
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K152479
Device Name
HG PRO® Nitrile Powder Free Examination Gloves
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/1 description: The image shows a logo for the "SRITONG GROUP". The logo consists of two overlapping shapes: a pink circle on the left and a white hexagon on the right. Inside the pink circle are horizontal lines, and inside the hexagon are the letters "HG" in blue. The text "SRITONG GROUP" is written in blue below the logo.
ongkhla 90230, Thailand Tel: +66 74 536815 Fax: +66 74
510(k) SUMMARY HG PRO® Nitrile Powder Free Examination Gloves
1.0 Submitter:
| Applicant: | Healthy Glove Co., Ltd | |
|---|---|---|
| 119 Kanchanavanich Road, Tambol Patong | ||
| Hat Yai, Songkhla 90230 | ||
| Thailand | ||
| Phone Number: | +66 74 536 815 | |
| Fax Number: | +66 74 536 816 | |
| Name of Contact Person: | Teoh, Choh Shee | |
| Preparation date: | January 15, 2016 |
2.0 Name of Device:
| Trade/Proprietary Name(s): | HG PRO® Nitrile Powder Free Examination Gloves |
|---|---|
| Common Name: | Patient Examination Glove |
| Classification Name: | Patient Examination Gloves (21 CFR 880.6250 product code LZA) |
| Device Class: |
3.0 Identification of The Legally Marketed Devices that equivalency is claimed
| Device Name: | MEDTEXX™ Blue Colour Powder Free Nitrile Rubber Examination
Glove |
|-------------------|----------------------------------------------------------------------|
| Manufacturer: | Latexx Manufacturing Sdn., Bhd |
| 510(k): | K022548 |
| MDL: | - |
| Regulatory Class: | I |
| Product Code: | LZA |
4.0 Description of the Device:
HG PRO® Nitrile Powder Free Examination Gloves are substantially equivalent to the Class 1 patient examination gloves bearing the product code Nitrile - LZA (21CFR 880.6250). They meet all the current specifications listed under the ASTM Specification D 6319 -10, Standard Specification for
4
Image /page/4/Picture/0 description: The image shows a logo for the "SRITONG GROUP". The logo consists of two pink circles, one containing horizontal lines and the other containing the letters "HG" in blue inside of a white hexagon. The text "SRITONG GROUP" is written in blue below the logo.
Nitrile Examination Gloves for Medical Application. They are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.
5.0 Intended Use of the Device:
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.
6.0 Summary of Technological Characteristics Compared to the Predicate Device:
There are no different technological characteristics of the Subject Device compared to the Predicate Device.
HG PRO® Nitrile Powder Free Examination Gloves are summarized with the following technological characteristics compared to ASTM D 6319 or equivalent standards as shown in Table 1.
| Characteristics | Reference/Standards | Predicate: K022548
Non-Sterile, Powder Free Nitrile
Examination glove | Subject Device:
New 510(k) submission
Non-Sterile, Powder Free Nitrile
Examination glove |
|------------------------------|--------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer(s) | | Latexx Manufacturing Sdn., Bhd. | Healthy Glove Co., Ltd |
| Indication for Use | Medical Gloves Guidance
Manual | 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 | 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 |
| Material | ASTM D6319-10 | Nitrile Synthetic Rubber | Nitrile Synthetic Rubber |
| Color | - | Blue | Blue |
| Texture | - | Textured Fingers | Textured Fingers |
| Size | Medical Glove Guidance
Manual-Labeling- Issued
on January 22, 2008 | Extra Small
Small
Medium
Large
Extra Large | Extra Small
Small
Medium
Large
Extra Large |
| Single Use | Medical Gloves Guidance
Manual -Issued on
January 22, 2008 | Single use | Single use |
| Characteristics | Acceptance
Criteria/Standards | Predicate: K022548
Non-Sterile, Powder Free
Nitrile Examination glove | Subject Device:
New 510(k) submission
Non-Sterile, Powder Free
Nitrile Examination glove |
| Dimension | ASTM D6319-10 | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| | | | Length |
| | | | Extra Small = 220 mm minimum
Small = 220 mm minimum
Medium = 230 mm minimum
Large = 230 mm minimum
Extra Large = 230 mm
minimum |
| | | | Palm Width |
| | | | Extra Small = 60-80 mm
Small = 70-90 mm
Medium = 85-105 mm
Large = 100-120 mm
Extra Large = 110-130 mm |
| | | | |
| Thickness | ASTM D6319-10 | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| | | | Finger: 0.05 mm min |
| | | | Palm: 0.05 mm min |
| Physical
Properties | ASTM D6319-10 | Meet ASTM D6319-10 | Meet ASTM D6319-10 |
| | | | Tensile Strength: |
| | | | 14 MPa min (before aging) |
| | | | 14 MPa min (after aging) |
| | | | Ultimate Elongation: |
| | | | 500% min (before aging) |
| | | | 400% min (after aging) |
| Watertight test
(1000 ml) | ASTM D5151-06 | Pass | Pass AQL 1.5 |
| Residual Powder | ASTM D6124-06 | Meet
≤ 2.0 mg/glove | Meet
≤ 2.0 mg/glove |
| Biocompatibility | Primary Skin Irritation - ISO
10993-10: 2010 | Pass | Pass |
| | | | Not a primary skin irritant
under the conditions of the
study |
| | | | |
| | Dermal Sensitization - ISO
10993-10: 2010 | Pass | Not a contact sensitizer under
the conditions of the study |
Table 1. Side-by-Side Comparison of Predicate Device with Subject Device: Indication for Use, Non-clinical Performance Data and Technological Characteristics
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Image /page/5/Picture/0 description: The image shows a logo for the "SRITONG GROUP". The logo consists of two pink circles that are connected. The left circle contains horizontal lines, and the right circle contains the letters "HG" in blue. The text "SRITONG GROUP" is located below the logo.
HEALTHY GLOVE CO., LTD., LTD.
119 Kanchanavanich Road, T. Patong, Hatyai, Songkhla 90230, Thailand
Tel: +66 74 536815 Fax: +6 74 536 816
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Image /page/6/Picture/0 description: The image shows a logo for the "SRITONG GROUP". The logo consists of two overlapping shapes: a pink circle on the left containing horizontal lines, and a white hexagon on the right containing the letters "HG" in blue. The text "SRITONG GROUP" is written in blue below the logo.
7.0 Substantial Equivalent Based on Assessment of Non-clinical Performance Data:
The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned in the previous section (ASTM Requirements).
8.0 Substantial Equivalent Based on Assessment of Clinical Performance Data:
No Clinical testing was required to determine substantial equivalence of this device.
9.0 Conclusion:
Based on the comparison of the intended use, technological characteristics and non-clinical performance test data, the Subject Device HG PRO® Nitrile Powder Free Examination Glove is substantially equivalent to the Predicate Device K022548