(154 days)
Not Found
No
The device is a disposable examination glove and the summary does not mention any AI/ML capabilities or related components.
No
The device, "Powder Free Nitrile Patient Examination Gloves," is intended to prevent contamination between patient and examiner, not to provide therapy or treatment for a disease or condition.
No
The device description clearly states its purpose is to prevent contamination between patient and examiner, not to diagnose any condition. The "Key Metrics" section lists physical properties of the glove, not diagnostic metrics.
No
The device is a physical product (gloves) made of nitrile, not software. The description focuses on material properties and performance standards for physical gloves.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This includes tests for diagnosis, monitoring, screening, and prognosis.
- Device Description and Intended Use: The description clearly states the device is a "powder free nitrile patient examination glove" intended to be "worn on the examiner's hands to prevent contamination between patient and examiner." This is a barrier device used externally on the hands.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze any biological specimens or provide diagnostic information based on such analysis.
- Focus on Physical Properties: The performance studies and key metrics listed (Tensile Strength, Ultimate Elongation, Freedom from Holes, Powder Content, Irritation, Sensitization) are all related to the physical properties and safety of the glove as a barrier, not its ability to perform diagnostic tests.
Therefore, based on the provided information, this device is a medical device, but it falls under the category of a Class I or Class II medical device (depending on the specific regulations and risk classification) used for barrier protection, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The powder free nitrile patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
Product codes
LZA
Device Description
The proposed device, Powder Free Nitrile Patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is Powder Free Nitrile Patient Examination Gloves, and includes variations of different size and color. The colors of proposed device is Blue.
The proposed device is not provided as sterilized. The proposed device is made of Nitrile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner / 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)
Bench tests were conducted to verify that the proposed device met all design specifications as compared to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ASTM D6319-10 (Reapproved 2015), Standard Specification for Nitrile Examination Gloves for Medical Application.
ASTM D 5151-06 (Reapproved 2011), Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6124-06 (Reaffirmation 2011), Standard Test Method for Residual Powder on Medical Gloves.
ISO 2859-1:1999, "Sampling Procedures for Inspection by Attributes - Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection.
ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked one behind the other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Hebei Titans Medical Supply Technology Group.,ltd. % Ray Wang Official Correspondent Beijing Believe Tech. Service Co., Ltd. 5-1206, Build 332, Dafangju, No.25 Banbidian Rd., Li Yuan, Tongzhou District Beijing, BeiJing 101121 CN
Re: K163553
Trade/Device Name: Powder Free Nitrile Patient Examination Gloves, Blue Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: April 27, 2017 Received: May 1, 2017
Dear Ray Wang:
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 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,
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) K163553
Device Name
Powder Free Nitrile Patient Examination Gloves, Blue
Indications for Use (Describe)
The powder free nitrile patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and 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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3
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) Number: K163553
-
- Date of Preparation: 2017/05/16
-
- Sponsor
HEBEI TITANS MEDICAL SUPPLY TECHNOLOGY GROUP CO., LTD. EAST OF JINGQIANG COMMUNITY, DAQING STREET, NANGONG, XINGTAI, HEBEI PROVINCE, CHINA
Contact Person: Mr. ShaoZhang Nan Tel: +86-0319-7295820 Fax: +86-0319-7295801 Email: nanshaozhang@163.com
-
Submission Correspondent 3. Mr. Ray Wang
Beijing Believe Tech. Service Co., Ltd. Email: Ray.Wang@believe-med.com -
- Proposed Device Identification
Trade Name: Powder Free Nitrile Patient Examination Gloves, Blue Device Name: NITRILE Patient Examination Gloves (Powder Free) Common Name: Patient Examination Gloves
- Proposed Device Identification
Classification: I Product Code: LZA Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital
Indication for Use Statement:
The powder free nitrile patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
4
-
Predicate Device Identification 5.
510(k) Number: K131440 Product Name: Powder free Patient Examination Gloves, Blue Color Manufacturer: Hebei HongSen Plastics Technology Co., Ltd. -
- Device Description
The proposed device, Powder Free Nitrile Patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
- Device Description
The proposed device is Powder Free Nitrile Patient Examination Gloves, and includes variations of different size and color. The colors of proposed device is Blue.
The proposed device is not provided as sterilized The proposed device is made of Nitrile.
-
- Non-Clinical Test Conclusion
Bench tests were conducted to verify that the proposed device met all design specifications as compared to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
ASTM D6319-10 (Reapproved 2015), Standard Specification for Nitrile Examination Gloves for Medical Application.
ASTM D 5151-06 (Reapproved 2011), Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6124-06 (Reaffirmation 2011), Standard Test Method for Residual Powder on Medical Gloves.
ISO 2859-1:1999, "Sampling Procedures for Inspection by Attributes - Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection.
ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
5
8. Substantially Equivalent Comparison Conclusion
| Table III-1 General Comparison | |||
|---|---|---|---|
| ITEM | Proposed Device | ||
| Powder Free Nitrile Patient Examination | |||
| Gloves, Blue | Predicate Device (K131440) Powder free | ||
| Patient Examination Gloves, | |||
| Blue Color | Remark | ||
| Product Code | LZA | LZA | Same |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Indication for | |||
| Use | The powder free nitrile patient examination | ||
| glove is a disposable device intended for | |||
| medical purposes that is worn on the | |||
| examiner's hands to prevent contamination | |||
| between patient and examiner. | The Titan powder free nitrile patient | ||
| examination glove, blue color, is a | |||
| disposable device intended for medical | |||
| purposes that is worn on the examiner's | |||
| hands or finger to prevent contamination | |||
| between patient and examiner. It has blue | |||
| color and is sold as non-sterile. | Same | ||
| Powdered or | |||
| Powered free | Powdered free | Powdered free | Same |
| Design Feature | ambidextrous, smooth | ambidextrous, smooth | Same |
| Labeling | |||
| Information | Single-use indication, powder free, device | ||
| name, glove size and quantity, Nitrile | |||
| Examination Gloves, Non-Sterile | Single-use indication, powder free, device | ||
| name, glove size and quantity, Nitrile | |||
| Examination Gloves, Non-Sterile | Same |
Table III-1 General Comparison
Table III-2 Device Dimensions Comparison
| Proposed Device
Powder Free Nitrile Patient Examination
| Gloves, Blue | Designation | Size | Tolerance | |||||
|---|---|---|---|---|---|---|---|---|
| Length, mm | XS | S | M | L | XL | min | ||
| Width, mm | 70 | 80 | 95 | 110 | 120 | $\pm$ 10 | ||
| Thickness, mm: | ||||||||
| Finger | 0.10 | $\pm$ 0.03 | ||||||
| Palm | 0.08 | $\pm$ 0.03 | ||||||
| Cuff | 0.06 | $\pm$ 0.03 | ||||||
| Predicate Device (K131440) | ||||||||
| Powder free Patient Examination | ||||||||
| Gloves, Blue Color | ||||||||
| Remark | Designation | XS | S | M | L | XL | XXL | Tolerance |
| Different 1 |
6
Different 1 analysis:
The proposed device has different size specification to the predicate device, and all specific size specifications for the predicate are not available for comparison, but the predicate and proposed device both meet the specifications of ASTM D 6319.
| ITEM | Proposed Device | Predicate Device (K131440) | Remark | |
|---|---|---|---|---|
| Colorant | Powder Free Nitrile Patient | |||
| Examination Gloves, Blue | Powder free Patient Examination | |||
| Gloves, Blue Color | Same | |||
| Physical | ||||
| Properties | ||||
| Before | ||||
| Aging | Tensile | |||
| Strength | 15 MPa, | Comply with ASTM D6319 | Same | |
| Ultimate | ||||
| Elongation | 500 % min | Comply with ASTM D6319 | Same | |
| Physical | ||||
| Properties | ||||
| After | ||||
| Aging | Tensile | |||
| Strength | 14 MPa | Comply with ASTM D6319 | ||
| Ultimate | ||||
| Elongation | 400 % min | Comply with ASTM D6319 | ||
| Comply with ASTM D6319 | Comply with ASTM D6319 | Comply with ASTM D6319 | Same | |
| Freedom from Holes | Be free from holes when tested in | |||
| accordance with ASTM D5151 | Be free from holes when tested | |||
| in accordance with ASTM | ||||
| D5151 | Same | |||
| Powder Content | Max. 0.32 mg per glove | Meet the requirements of ASTM | ||
| 6319 | Same |
Table III-3 Performance Comparison
Table III-4Safety Comparison
| ITEM | Proposed Device Powder
Free Nitrile Patient
Examination Gloves, Blue | Predicate Device (K131440)
Powder free Patient Examination
Gloves, Blue Color | Remark |
|--------------------|----------------------------------------------------------------------------|-------------------------------------------------------------------------------------|--------|
| Material | Nitrile | Nitrile | Same |
| Biocompatibility | Irritation
Under the conditions of the study,
not an irritant | Comply with ISO 10993-10 | Same |
| | Sensitization
Under conditions of the study, not a
sensitizer. | | |
| Label and Labeling | Meets recommendations as outlined
in the Glove Guidance Manual. | Meets recommendations as outlined
in the Glove Guidance Manual. | Same |
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.