(148 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of examination gloves, with no mention of AI or ML.
No
The device is a glove for preventing contamination, not for treating a disease or condition.
No
The device, a Powder Free Vinyl Patient Examination Glove, is described as a barrier to prevent contamination, not for diagnosing conditions. Its function is protective, not analytical or indicative of a medical condition.
No
The device is a physical glove made of PVC, not software. The description details its material properties and physical function as a barrier.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used during physical examination or procedures.
- Device Description: The description focuses on the physical properties of the glove (PVC film, barrier to body fluids and bloodborne pathogens, tensile properties) and its manufacturing standards (ASTM). It does not mention any components or processes related to testing samples of human origin in vitro.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
- Performance Studies: The performance studies mentioned are related to the physical properties and safety of the glove (ASTM standards, biocompatibility), not the accuracy or performance of a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This glove's function is purely as a physical barrier.
N/A
Intended Use / Indications for Use
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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.
Product codes (comma separated list FDA assigned to the subject device)
LYZ
Device Description
PVC films form a barrier to body fluids and bloodborne Pathogens. The PVC 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. Poly (vinyl chloride) 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 D5250 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 / 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)
Non-clinical performance data showed that Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) meet requirements per ASTM D5250-06 (Reapproved 2011), per ASTM D6124-06 Reaffirmation 2011), per 21 CFR 800.20 and ISO 10993-10:2010-08-01.
Performance characteristics evaluated:
- Dimensions (Length, Width, Thickness)
- Physical Properties (Tensile strength, Elongated rate)
- Freedom from pinholes
- Powder Residual
- Biocompatibility (Primary Skin Irritation in rabbits, Dermal sensitization in the guinea pig)
Key Results:
- Dimensions: Length 232-240mm; Width (Small 80-90 mm, Medium 93-98mm, Large 102-109mm, X large 110-118mm); Thickness (Fingertip 0.08-0.11 mm, Palm 0.09-0.12 mm)
- Physical Properties: Tensile strength 15-20MPa; Elongated rate 360-420%
- Freedom from pinholes: Passed Standard (Acceptance Criteria)
- Powder Residual: Meets
§ 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 is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, layered on top of each other, suggesting a sense of community and support. The profiles are rendered in a simple, elegant design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 17, 2015
Daxwell, LLC c/o Chu Xiaoan Beijing Easylink CO., LTD Rm. F302 Bldg., 41. Jing Cheng Ya Ju Courtyard 6 of Southern Dou Ge Zhang Chaoyang District Beijing 100121 CHINA
Re: K151682
Trade/Device Name: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient examination glove Regulatory Class: Class I Product Code: LYZ Dated: October 4, 2015 Received: October 16, 2015
Dear Mr. Chu 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.
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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 (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/Resourcesfor You/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 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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Indications for Use
510(k) Number (if known) K151682
Device Name
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Indications for Use (Describe)
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Section C 510(k) Summary
510(K) Summary
"The assigned 510(k) number is: _ _ _ K151682
Premarket Notification [510(k)] Summary
0.0 Application correspondent:
| Company name | Beijing Easy-Link Company |
|---|---|
| Company address | Rm. F302 Bldg., 41, Jing Cheng Ya Ju, |
| Courtyard 6 of Southern Dou Ge Zhuang, | |
| Chaoyang District, Beijing 100121, | |
| P.R.China | |
| Contact Person | Chu Xiaoan |
| Contact E-mail address | easylink_bj@aliyun.com |
1.0 Submitter:
| Submitter's name : | Daxwell, LLC |
|---|---|
| Submitter's address : | Address: 2825 Wilcrest Dr., Suite# 500 |
| Houston, TX 77042,USA. | |
| Phone number : | (281)669-0622 |
| Fax number : | (281)669-0617 |
| Name of contact person: | Frank Zhang |
| Date of preparation : | 2015-11-17 |
2.0 Name of the Device
| Device Name: | Powder Free Vinyl Patient Examination
Gloves, Clear (non-colored) |
|-------------------------|----------------------------------------------------------------------|
| Proprietary/Trade name: | Powder Free Vinyl Patient Examination
Gloves, Clear (non-colored) |
| Common Name: | Exam gloves |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital (80) |
| Product Code: | LYZ |
3.0 Predicate device
| Device Name: | Powder-Free Vinyl Patient Examination Glove
(Non-colored) |
|----------------|--------------------------------------------------------------|
| Company name: | Zhang Jia Gang Fengyuan Plastic Product Co. Ltd. |
| 510(K) Number: | K091663. |
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4.0 Device Description:
4.1 How the device functions:
PVC films form a barrier to body fluids and bloodborne Pathogens
4.2 Scientific concepts that form the basis for the device
The PVC 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.
- 4.3 Physical and performance characteristics such as design, materials and physical properties:
Poly (vinyl chloride) 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 D5250 and ASTM D5151 requirements.
5.0 Device Intended Use (Indication for use):
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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.
6.0 Summary of the Technological Characteristics of the Device:
The Powder Free Vinyl Patient Examination Gloves, Clear (non-colored), non-sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Characteristics | Standard | Device performance | ||
|---|---|---|---|---|
| Dimension | ASTM D 5250-06(Reapproved 2011). | |||
| Length | ≥230mm | 232-240mm | ||
| Width | Small | 80-90 mm | 81-90mm | |
| Medium | 90-100mm | 93-98mm | ||
| Large | 100-110mm | 102-109mm | ||
| X large | 110-120 mm | 110-118mm | ||
| Thickness | Fingertip | ≥0.05mm | 0.08-0.11 mm | |
| Palm | ≥0.08mm | 0.09-0.12 mm | ||
| Physical Properties | ASTM D 5250-06(Reapproved 2011). | |||
| Tensile strength | ||||
| (Before & After aging) | ≥11MPa | 15-20MPa | ||
| Elongated rate | ||||
| (Before & After aging) | ≥300% | 360-420% | ||
| Freedom from | ||||
| pinholes | • | 21 CFR 800.20 | Passed Standard | |
| • | ASTM D5250-06(Reapproved 2011) | Acceptance Criteria | ||
| • | ASTM D5151-06(Reapproved 2011) | |||
| Powder Residual | ASTM standard D 5250-06 (Reapproved | |||
| 2011).and D6124-06(Reaffirmation 2011) | Meets |