(202 days)
Not Found
No
The device description and performance studies focus on the physical properties and material of examination gloves, with no mention of AI or ML.
No
The device is described as a "patient examination glove" intended to "prevent contamination between patient and examiner," indicating a barrier function rather than a therapeutic effect.
No
Explanation: The device described is a patient examination glove, which is used to prevent contamination between patient and examiner. It does not perform any diagnostic function such as detecting, diagnosing, or monitoring a disease or condition.
No
The device is a physical examination glove, not a software application. The description focuses on material properties and physical performance standards.
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 "patient examination glove...worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a physical barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description details the material and physical characteristics of a glove, not components or reagents used for testing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on physical properties, freedom from holes, and biocompatibility (skin irritation/sensitization), which are relevant for a barrier device, not an IVD.
IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This glove does not fit that description.
N/A
Intended Use / Indications for Use
A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Product codes
LZA
Device Description
Powder Free Polyethylene Examination Gloves are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of translucent (clear) Low Density Polyethylene materials and are powder free. The gloves are loose fitting. The physical and performance characteristics of the devices meet all requirements of ASTM standard D-5250-06 (2011) Standard Specification for Poly(vinyl Chloride) Gloves for Medical Application.
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)
Non-Clinical Tests Performed:
- Dimensions: ASTM D 5250-06 (2011), Meets
- Physical Properties: ASTM D 5250-06 (2011), Meets
- Freedom from holes: ASTM D 5250-06 (2011), FDA 21CFR800.20, Meets
- Residual Powder Test: ASTM D 5250-06 (2011), ASTM D6124-06 (Reapproved 2011), Meets
- Primary Skin Irritation and Skin Sensitization: ISO 10993 Part 10, Meets
Clinical Tests Performed: Not Applicable - There is no hypoallergenic Claim. There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The substantial equivalence of the device is supported by the nonclinical testing.
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
Donggao Industrial Zone, Zanhuang, Hebei, China 050000
Product: Powder Free Polyethylene Examination Gloves
JUN - 2 2014
510(K) SUMMARY
This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR §807.92.
The assigned 510(K) number is: K133478
l. Owner's Identification:
Ms. Huizhen Qu Shijiazhuang Hongzan Plastic Technology Co., Ltd Donggao Industrial Zone, Zanhuang, Hebei, China 050000
Tel: 86-311-83601854 Fax: 86-311- 83616934
Contact: Ms. Kathy Liu, Project Manager Address: 3973 Schaefer Ave., Chino, CA 91710 Tel: 909-590-1611 Fax: 909-590-1511 Date Summary Prepared: April 19, 2014
2. Name of the Device:
Trade Name: Powder Free Polyethylene Examination Gloves Common Name: Exam Gloves Classification Name: Patient Examination Glove Classification Regulation: 880.6250 Classification Panel: 880 General Hospital and Personal Use Product Code: LZA Device Class: Class I
3. Predicate Device Information:
AmerCare Inc. C2 Powder Free Polyethylene Examination Glove (K113639)
4. Device Description:
Powder Free Polyethylene Examination Gloves are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of translucent (clear) Low Density Polyethylene materials and are powder free. The gloves are loose fitting. The physical and performance characteristics of the devices meet all requirements of ASTM standard D-5250-06 (2011) Standard Specification for Poly(vinyl Chloride) Gloves for Medical Application.
1
Donggao Industrial Zone, Zanhuang, Hebei, China 050000
Product: Powder Free Polyethylene Examination Gloves
5. Intended Use of the Device:
A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
6. Technological Characteristics and Substantial Equivalence:
Shijiazhuang Hongzan Plastic Technology Co., Ltd.'s Powder Free Polyethylene Examination Gloves is substantially equivalent in safety and effectiveness to the AmerCare Inc.'s C2 Powder Free Polyethylene Examination Glove (K113639). The subject device and predicate device use a similar plastic flexible barrier film to achieve a device for the intended use.
And the properties between the subject device and the predicate device are compared in the following table: Device Performance Result of Characteristics Standard Dradicate Device Subject Device omnarison
| Product Code | Predicate Device | Subject Device | comparison | |
|---|---|---|---|---|
| Product Code | / | LZA | LZA | Substantial |
| equivalence | ||||
| Intended Use | / | Predicate device is | ||
| a disposable device | ||||
| intended for | ||||
| medical purpose | ||||
| that is worn on the | ||||
| examiner's hand or | ||||
| finger to prevent | ||||
| contamination | ||||
| between patient | ||||
| and examiner. | Subject device is | |||
| disposable non- | ||||
| sterile device | ||||
| intended for | ||||
| medical purpose | ||||
| that is worn on the | ||||
| examiner's hand or | ||||
| finger to prevent | ||||
| contamination | ||||
| between patient | ||||
| and examiner. | Substantial | |||
| equivalence | ||||
| Labeling | / | There are no | ||
| special labeling | ||||
| claims and do not | ||||
| claim gloves as | ||||
| hypoallergenic on | ||||
| labels. | There are no | |||
| special labeling | ||||
| claims and do not | ||||
| claim gloves as | ||||
| hypoallergenic on | ||||
| labels. | Substantial | |||
| equivalence | ||||
| Device | ||||
| Materials | / | Polyethylene | Polyethylene | Substantial |
| equivalence | ||||
| Color | / | Translucent (Clear) | Translucent (Clear) | Substantial |
| equivalence |
2
Donggao Industrial Zone, Zanhuang, Hebei, China 050000
| Standard | Device Performance | Result of | |||
|---|---|---|---|---|---|
| Characteristics | Predicate Device | Subject Device | comparison | ||
| Device tolerances and specifications & Performance Data: | |||||
| Tensile | |||||
| strength: | |||||
| before | |||||
| and | |||||
| after | |||||
| aging | ASTM | ||||
| D5250-06 (2011) | Meets | Meets | Substantial | ||
| equivalence | |||||
| Ultimate | |||||
| elongation: before | |||||
| and after aging | ASTM | ||||
| D5250-06 (2011) | Meets | Meets | Substantial | ||
| equivalence | |||||
| Freedom | |||||
| from | |||||
| pinholes | ASTM | ||||
| D5250-06 (2011) | Meets | Meets | Substantial | ||
| equivalence | |||||
| Dimensions: | |||||
| Overall | |||||
| length, | |||||
| Width, Palm and | |||||
| Finger thickness | ASTM | ||||
| D5250-06 (2011) | Meets | Meets | Substantial | ||
| equivalence | |||||
| Residual powder | ASTM | ||||
| D5250-06 (2011) | |||||
| ASTM D6124-06 | Meets | Meets | Substantial | ||
| equivalence | |||||
| Biocompatibility | |||||
| Primary skin irritation test | Passes | ||||
| Not a primary skin | |||||
| irritation | Passes | ||||
| Not a primary skin | |||||
| irritation | Substantial | ||||
| equivalence | |||||
| Dermal sensitization assay | Passes | ||||
| Not a dermal | |||||
| sensitization | Passes | ||||
| Not a dermal | |||||
| sensitization | Substantial | ||||
| equivalence |
Product: Powder Free Polyethylene Examination Gloves
Shijiazhuang Hongzan Plastic Technology Co., Ltd's Powder Free Polyethylene Examination Gloves shares the same technology characteristics compared to the predicate device. The subject device performs according to the glove performance standards ASTM D5250-06(2011), biocompatibility requirement and FDA requirements and the labeling claims for the product. It performs as well as the legally marketed predicate device.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows:
| Characteristics | Applicable
Recognized Standards | Performance Results |
|---------------------|------------------------------------------|---------------------|
| Dimensions | ASTM D 5250-06 (2011) | Meets |
| Physical Properties | ASTM D 5250-06 (2011) | Meets |
| Freedom from holes | ASTM D 5250-06 (2011)
FDA 21CFR800.20 | Meets |
3
Donggao Industrial Zone, Zanhuang, Hebei, China 050000
| Characteristics | Applicable FDA-Recognized Standards | Performance Results |
|---|---|---|
| Residual Powder Test | ASTM D 5250-06 (2011) | |
| ASTM D6124-06 | ||
| (Reapproved 2011) | Meets | |
| Primary Skin Irritation | ||
| and Skin Sensitization | ISO 10993 Part 10 | Meets |
Product: Powder Free Polyethylene Examination Gloves
8. Discussion of Clinical Tests Performed:
Not Applicable - There is no hypoallergenic Claim. There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The substantial equivalence of the device is supported by the nonclinical testing.
9. Labeling:
There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels.
10. Conclusions:
Shijiazhuang Hongzan Plastic Technology Co., Ltd.'s Powder Free Polyethylene Examination Gloves conform fully to ASTM D-5250-06(2011) standard as well as applicable 21 CFR references, and meets pinhole FDA requirements, biocompatibility requirements and labeling claims as shown by data discussed above. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited. Drawn from the complete list of non-clinical tests, the device herein mentioned is as safe, as effective, and performs as well as the predicate device.
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 2, 2014
Shijiazhuang Hongzan Plastic Technology Company, Limited C/O Ms. Kathy Liu Official Correspondent Hongray USA Medical Products Incorporated 3973 Schaefer Avenue Chino, CA 91710
Re: K133478
Trade/Device Name: Powder Free Polyethylene Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: April 19, 2014 Received: April 30, 2014
Dear Ms. Liu:
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.
5
Page 2 - Ms. Liu
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.ida.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
6
Indications for Use
510(k) Number (if known) K133478
Device Name
Powder Free Polyethylene Examination Gloves
Indications for Use (Describe)
A patient examination glove is disposable non-sterile device intended for medical purpose 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)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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FORM FDA 3881 (9/13)
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
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