(170 days)
Not Found
No
The device is a standard examination glove and the description focuses on its physical properties and barrier function, with no mention of AI or ML.
No
The device is a non-sterile disposable glove intended to prevent contamination between patient and examiner, not to treat or diagnose a disease or condition.
No
The device is a non-sterile disposable glove intended to prevent contamination between patient and examiner, serving as a barrier rather than for diagnostic purposes.
No
The device description clearly states it is a physical glove made of nitrile, intended to be worn on the hand or finger. It describes physical properties and testing related to material and barrier function, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the physical properties of the glove as a barrier to body fluids and pathogens. It does not describe any mechanism for analyzing samples or providing diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or providing any kind of diagnostic result or interpretation.
- Performance Studies: The performance studies listed are related to the physical properties and biocompatibility of the glove (dimension, tensile strength, freedom from pinholes, etc.), not diagnostic accuracy or performance metrics like sensitivity or specificity.
- Regulatory Classification: Patient examination gloves are typically classified under a different regulatory category than IVDs.
In summary, this device is a medical device intended for barrier protection, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
Nitrile Powder Free Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Product codes
LZA
Device Description
Nitrile films form a barrier to body fluids and bloodborne Pathogens. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Nitrile glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.
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
The Nitrile Powder Free Patient Examination Gloves, Blue Color, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
Dimensions: Meets ASTM standard D 6319-10.
Physical Properties: Meets ASTM standard D 6319-10.
Freedom from pinholes: Meets 21 CFR 800.20
Powder Residual: Meets ASTM standard D 6319-10 and D6124-06(Reapproved 2011).
§ 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 eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 9, 2016
Zhonghong Pulin Medical Products Co., Ltd. c/o Mr. Chu Xiaoan Room 1606 Bldg. 1, Jianxiang Yuan No. 209 Bei Si Huan Zhong Road, Haidian District Beijing 100083 CHINA
Re: K152712
Trade/Device Name: Nitrile Powder Free Patient Examination Gloves, Blue Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: January 28, 2016 Received: February 1, 2016
Dear Mr. Xiaoan:
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
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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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Nitrile Powder Free Patient Examination Gloves, Blue Color
Indications for Use (Describe)
Nitrile Powder Free Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger 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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Section 6 510(k) Summary
510(K) Summary
"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."
= "The assigned 510(k) number is: K152712
Premarket Notification [510(k)] Summary
1.0 Submitter:
| Submitter's name : | Zhonghong Pulin Medical Products Co.,Ltd. |
|---|---|
| Submitter's address : | Pachigang Industrial Park,Luannan County, |
| Tangshan City, 063502 Hebei, China | |
| Phone number : | (86)315-4165760 |
| Fax number : | (86)315-4167664 |
| Name of contact person: | LI Jinge |
| Date of preparation : | 2016-03-02 |
2.0 Name of the Device
| Device Name: | Nitrile Powder Free Patient Examination
Gloves, Blue Color |
|-------------------------|-------------------------------------------------------------------------------|
| Proprietary/Trade name: | Zhonghong Pulin Nitrile Powder Free Patient
Examination Gloves, Blue Color |
| Common Name: | Exam gloves |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital (80) |
| Product Code: | LZA |
3.0 Predicate device
| Device Name: | Nitrile Powder Free Patient Examination Gloves, |
|---|---|
| Blue Color | |
| Company name: | Tangshan Zhonghong Pulin Plastic Co.,Ltd. |
| 510(K) Number: | K120970 |
4.0 Device Description:
4.1 How the device functions:
Nitrile films form a barrier to body fluids and bloodborne Pathogens
4.2 Scientific concepts that form the basis for the device
The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a
4
medical procedure.
4.3 Physical and performance characteristics such as design, materials and physical properties:
Nitrile glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.
5.0 Device Intended Use (Indication for use):
Nitrile Powder Free Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
6.0 Summary of the Technological Characteristics of the Device:
The Nitrile Powder Free Patient Examination Gloves, Blue Color, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Characteristics | Standard | Device performance | |
|---|---|---|---|
| Dimension | ASTM standard D 6319-10. | Meets | |
| Physical Properties | ASTM standard D 6319-10. | Meets | |
| Freedom | |||
| from | |||
| pinholes | 21 CFR 800.20 | Meets | |
| Powder Residual | ASTM standard D 6319-10 and | Meets | |
| D6124-06(Reapproved 2011). |