(613 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of a patient examination glove, with no mention of AI or ML.
No
Explanation: The device is a patient examination glove used to prevent contamination between patient and examiner, not to treat or alleviate a disease or condition.
No
Explanation: The device is a patient examination glove, described as a barrier to contamination between patient and examiner and to body fluid and blood-borne pathogens. Its purpose is protective, not diagnostic.
No
The device description clearly indicates a physical garment (glove) made of vinyl film, designed to be worn on the hands. There is no mention of software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between patient and examiner by being worn on the hands. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the physical properties of the glove as a barrier and its conformity to the hand for medical procedures. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
- Classification: The device is classified as Class I by the FDA's General and Plastic Surgery Device panel, which is consistent with a physical barrier device, not an IVD. IVDs typically fall under different classifications and panels.
Therefore, the information clearly indicates that this device is a medical glove intended for barrier protection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner.
Product codes
LYZ
Device Description
Classified by FDA's General and Plastic Surgery Device panel as Class I, and meets all requirement of ASTM Standard D5250-06. The subject device is a garment covering the hand and wrist area. Clovers have separate sheaths or openings for each finger and the thumb. And vinyl films form a barrier to body fluid and blood-borne pathogens, and that the vinyl rubber is water tight under normal conditions of use. Its tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands 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)
The standards used for Shandong Yifan Plastic Products Co., Ltd. glove production are based on ASTM-D-5250-06. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 2.5.
The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, Inspection Level I, meeting these requirements, Primary Skin irritation and Skin Sensitization testing was conducted with results showing no primary skin irritant or sensitization reactions.
The subject gloves are powder free.
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
510 (K) SUMMARY
MAY 0 6 2014
This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21CFR 807.92.
1. Submitter's Identification:
Shandong Yifan Plastic Products Co., Ltd. Building 11, Sunny Industries Park, Shuangyang Village, Zichuan District, Zibo City, Shandong, China 255000 Date summary prepared: April 15, 2014
2. Name of the Device:
Shandong Yifan Plastic Products Co., Ltd. Powder-free Vinyl Patient Examination Gloves, Yellow Color
3. Common name/classification name of the Device:
Regulation Number: 21 CFR 880.6250, Regulation Name: Patient Examination Glove Regulation Class: Class I Product Code: LYZ
4. Contact Person:
Jennifer Guo, Tel: 909-548-4828
ડ. Predicate Device Information:
Shijiazhuang Hongxiang Plastic Products Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free (K992821)
6. Device Description:
Classified by FDA's General and Plastic Surgery Device panel as Class I, and meets all requirement of ASTM Standard D5250-06. The subject device is a garment covering the hand and wrist area. Clovers have separate sheaths or openings for each finger and the thumb. And vinyl films form a barrier to body fluid and blood-borne pathogens, and that the vinyl rubber is water tight under normal conditions of use. Its tensile
1
properties cause it to conform to the hand, allowing movements necessary for a medical procedure.
7. Intended Use:
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner.
8. Comparison to Predicate Devices:
Shandong Yifan Plastic Products Co., Ltd. Powder-free Vinyl Patient Examination Gloves, Yellow Color are substantially equivalent in safety and effectiveness to the Shijiazhuang Hongxiang Plastic Products Co., Ltd.(K992821)
Table 7-2. Side-by-Side Comparison of Intended Use, Design, Material, Physical, Biocompatibility, and Performance Testing
| Proposed Device | Predicate Device (K992821) | |
|---|---|---|
| Description | Shandong Yifan Plastic Products Co., | |
| Ltd Powder-Free Vinyl Patient | ||
| Examination Gloves, Yellow Color | Shijiazhuang Hongxiang | |
| Powder-free Vinyl Patient | ||
| Examination Gloves | ||
| Indication for Use | A patient examination glove is a | |
| disposable device intended for medical | ||
| purposes that is worn upon the | ||
| examiner's hands or fingers to prevent | ||
| contamination between patient and | ||
| examiner. | A patient examination glove is a | |
| disposable device intended for medical | ||
| purposes that is worn upon the | ||
| examiner's hands or fingers to prevent | ||
| contamination between patient and | ||
| examiner. | ||
| Labeling: Instruction | ||
| for use | A garment covering the hand and wrist | |
| area. Clovers have separate sheaths or | ||
| openings for each finger and the | ||
| thumb. | Substantially equivalent | |
| Labeling: Labels on | ||
| the carton | Labels include: Product name; color; | |
| "single use Only" size, piece count, lot | ||
| number, distributor name, and | ||
| manufacturer address. | Substantially equivalent | |
| Device Materials | Poly Vinyl Chloride | |
| Polyurethane | ||
| Diisononyl Phthalate (DINP) | Substantially equivalent | |
| Before Aging: Tensile | ||
| Strength(Mpa) and | ||
| Ultimate Elongations | Average Tensile Strength (Mpa): | |
| 16.9 | ||
| Average Ultimate Elongations: 550% | Substantially equivalent | |
| After Aging: Tensile | ||
| Strength (Mpa) | Average Tensile Strength (Mpa): | Substantially equivalent |
2
| Strength(Mpa) and
Ultimate Elongations | 14.4
Average Ultimate Elongations: 500% | |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Overall Length on
Medium Size | Average over 230mm | Substantially equivalent |
| Width of Palm on
Medium Size | Average 95mm | Substantially equivalent |
| Palm Thickness | Average 0.085 mm | Substantially equivalent |
| Figure Thickness | Average 0.090 mm | Substantially equivalent |
| Residual Powder | Residual powder content ≤ 2 mg per
glove per ASTM D6124-06. | Substantially equivalent |
| Pinhole Results | According to ASTM D5151-06,
Testing result indicates pinhole were
found less than two pieces gloves out
of 125 pieces gloves. AQL 2.5 is met. | Substantially equivalent |
| Biocompatibility
Result: Primary Skin
Irritation | Not a irritant | Substantially equivalent |
| Dermal Sensitization | Not a sensitizer | Substantially equivalent |
| Summary of
comparison | Shandong Yifan Plastic Products Co., Ltd Powder-Free Vinyl Patient
Examination Gloves, Non-Sterile, Yellow Color (subject device) and
Shijiazhuang Hongxiang Powder-free Vinyl Patient Examination Gloves
(predicate device) are substantially equivalent in all technological
characteristics, including tensile strength, ultimate elongations size, thickness, | |
Discussion of Non-Clinical tests performed for Determination of 9. Substantial Equivalence are as follows:
The standards used for Shandong Yifan Plastic Products Co., Ltd. glove production are based on ASTM-D-5250-06. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 2.5.
The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, Inspection Level I, meeting these requirements, Primary Skin irritation and Skin Sensitization testing was conducted with results showing no primary skin irritant or sensitization reactions.
The subject gloves are powder free.
י
3
Discussion of Clinical Tests Performed: 10.
Not Applicable
Conclusions: 11.
The subject device, Shandong Yifan Plastic Products Co., Ltd. Powder-Free Vinyl Patient Examination Gloves, Yellow Color, Non-Sterile, is substantially equivalent to the predicate device (K992821) Shijiazhuang Hongxiang Powder-free Vinyl Patient Examination Gloves, in intended use as well as technological characteristics, including tensile strength, ultimate elongations size, thickness, residual powder and pinhole.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circle around the eagle.
ood and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 6, 2014
Shandong Yifan Plastic Products Company Limited C/O Ms. Ling Zhu Official Correspondent 12390 East End Avenue Chino, CA 91710
Re: K122656
Trade/Device Name: Powder-Free Vinyl Patient Examination Gloves, Yellow Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: April 23, 2014 Received: April 25, 2014
Dear Ms. Zhu:
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 - Mr. Zhu
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 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/ReportalProblem/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.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Tejashri Purohit-Sheth, M.D.
Clinical Deputy Director
DAGRID/ODE/CDRH
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on tast page.
510(k) Number (il known) K 122656
Device Name
Powder-free Vinyl Patient Examination Gloves, Yellow Color
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands of fingers to prevent contamination between patient and examiner.
Type of Use (Select one or both, as applicable) [] Prescription Use (Part 21 CFR 801 Subpart D)
Do 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)
beth F. Clave ou=FDA, ou=Poople.
cn=Eizabeth F. Clav 12 12 12 03.03 STATE OF ST ਾ ਸਿੱਖ ਮੁਹੰਮ
FORM FDA 3881 (1/14)