(201 days)
Not Found
No
The device is a patient examination glove, a physical barrier device, and the summary describes only physical and material properties and testing. There is no mention of any computational or analytical functions that would involve AI/ML.
No
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
The device is a patient examination glove used to prevent contamination, not to diagnose a condition.
No
The device description clearly identifies the device as a physical product (gloves) and details physical testing and standards related to the material and performance of the gloves. There is no mention of software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for preventing contamination between patient and examiner by being worn on the hands or fingers. This is a physical barrier function, not a diagnostic test performed on a sample from the body.
- Device Description: The description focuses on the physical properties of the glove (material, powder-free status, testing for powder levels, meeting ASTM standards) and its classification as a Class 1 medical device for general and plastic surgery. It does not describe any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
- Any reagents, calibrators, or controls typically associated with IVDs.
- Regulatory Classification: The device is classified under 21 CFR 880.6250, which is for Patient Examination Gloves, not for IVD devices.
In summary, this device is a medical glove intended for barrier protection, not for performing diagnostic tests on biological samples.
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 of finger to prevent contamination between patient and examiner (21CFR 880.6250)
Product codes
LYZ
Device Description
A Powder-Free Vinyl Patient Examination Gloves'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 (21CFR 880.6250). Our Powder-Free Vinvl Patient Examination Gloves do not contain any UPS powder according to the results of testing conducted on the gloves. The residual powder testing is conducted per standards of ASTM D-6124-06, which demonstrates that the powder free glove is less than 2mg/pc. Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove. 80LYZ, and meets all requirement of ASTM Standard D5250-06.
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
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 Binxiang Medical 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 AOL 2.5. Inspection Level 1, meeting these requirements. Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JAN - 7 2014 Page I of 4
510 (K) SUMMARY
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 Binxiang Medical Products Co., Ltd. No.11, Longshan Road, Wolong Industry Park Linqu, Shandong, China
Contact Person: Jeffrey Wang Product Manager
Date summary prepared: Dec 05, 2013
-
- Name of the Device:
Shandong Binxiang Medical Products Co., Ltd. Powder-Free Vinyl Patient Examination Gloves, Non-Sterile
- Name of the Device:
:"
3. Common Name
Powder-Free Vinyl Patient Examination Gloves. Non-Sterile
4. Trade Name
Shandong Binxiang Medical Products Co., Ltd. Powder-Free Vinyl Patient Examination Gloves. Non-Sterile
Predicate Device Informaton: પં
Shijiazhuang Star Plastic Co., Ltd. Powder Free Vinyl Examination Gloves - (K100699)
Tangshan Zhonghong Pulin Food Products Co., Ltd. Powder Free Vinyl Examination Gloves - (K022091)
1
Device Description:
- 19:51 | 19:51 | 19:00 | A Powder-Free Vinyl Patient Examination Gloves'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 (21CFR 880.6250). Our Powder-Free Vinvl Patient Examination Gloves do not contain any UPS powder according to the results of testing conducted on the
gloves. The residual powder testing is conducted per standards of ASTM D-6124-06, which demonstrates that the powder free glove is less than 2mg/pc. Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove. 80LYZ, and meets all requirement of ASTM Standard D5250-06.
and the contraster of the county of the county of the county of the county of the county of 73, 10 Indication for Use: Markers 20, 2017 11:14 PM 1 1 1 1 1 in the same of the state and as the possible of the distinction of the most to the
. . . . 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 (21CFR-880.6250)
8. Comparison to Predicate Devices:
Shandong Binxiang Medical Products Co., Ltd. Powder-Free Vinyl Patient Examination Gloves are substantially equivalent in safety and effectiveness to Fangshan Zhonghong Pulin Food Products Co., I.Id. (K022091) and Shijiazhuang Star Plastic., Co., Ltd. (K100699) Powder-Free Vinyl Patient Examination Gloves. Please find table 7-2 below for comparison details.
Discussion of Non-Clinical tests performed for Determination of 9. Substantial Equivalence are as follows:
The standards used for Shandong Binxiang Medical 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 AOL 2.5. Inspection Level 1, meeting these requirements. Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.
- . . 6.
2
Page 3 of 4
There are no special labeling claims and we do not claim our gloves as hypoallergenic is conducted to insure that our gloves meet our "powder-free" claims (contain no more than 2 mg powder per glove).
10. Sterilization
There is no specific device for non-sterile examination gloves. Hand hygiene by rubbing with an alcohol-based hand rub or by washing with soup and water should be performed when appropriate.
11. Conclusions:
Shandong Binxiang Medical Products Co., Ltd. Powder-Free Vinyl Patient Examination Gloves conforms fully to ASTM-D-5250-06 standard as well as applicable 21 CFR references, and, meets pinhole FDA requirements, biocompatibility requirements and labeling claims as shown by data in Section 7. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited.
3
Page 4 of 4
ﺍﻟ
| Proposed Device | Predicate Device | Predicate Device | |
|---|---|---|---|
| Shandong Binxiang | (K022091) | ||
| Tangshan Zhonghong | (K100699) | ||
| Shijiazhuang Star | |||
| Medical Products Co., | Pulin Food Products | ||
| Plastic Co., Ltd Powder | |||
| Description | Ltd Powder Free Vinyl | Co., Lid Class I vinyl | Free Vinyl Patient |
| Patient Examination | patient examination | Examination Gloves. | |
| Gloves, Clear | gloves, powder-free | Clear | |
| Indication for | |||
| Use | Disposable device | Substantially equivalent | Substantially equivalent |
| intended for medical | |||
| purposes that is worn | |||
| on the examiner's hand | |||
| or finger to prevent | |||
| contamination between | |||
| patient and examiner | |||
| A garment covering the | Substantially equivalent | Substantially equivalent | |
| hand and wrist area. | |||
| Clovers have separate | |||
| Basic Design | sheaths or openings for | ||
| each finger and | |||
| the | |||
| thumb. | |||
| Materials Used | Poly Vinyl Chloride | Same | Same |
| Single Use | Yes | Yes | Yes |
| Size | S.M,L.XL | S.M.L.,XL | Information |
| Unavailable | |||
| Sterile | Not sterile | Not sterile | Not sterile |
| Dimension | Meets ASTM D5150- | Meets ASTM D5150-06 | Meets ASTM |
| D2150- | |||
| 06 | ૦ર | ||
| Physical | Meets | ||
| ASTM DS150- | Meets ASTM D5150-06 | Meets ASTM D5150- | |
| Property | 06 | ૦ર | |
| Free of Pinhole | Meets ASTM | ||
| DSISI- | Meets ASTM D5151-99 | Mecis 21 CFR 800.20 | |
| ರಿಗಿ | |||
| Residue Powder | Meets ASTM D6124- | Meets ASTM D6124-06 | Meets ASTM |
| D6124 | |||
| 06. | 06 | ||
| Primary Skin | ISO 10993-10 | ||
| passes. | SO 10993-10 passes | ISO 10993-10 passes | |
| Irritation. | The test material was | ||
| not irritating to the skin | |||
| of the rabbits | |||
| Dermal | ISO 10993-10 passes. . | ISO 10993-10 passes | ISO 10993-10 passes |
| Sensitization | An extract of this lest | ||
| material did not to | |||
| any skin | |||
| produce | |||
| irritation on the pigs | |||
Table 7-2: Side-by-Side Comparison of Intended Use, Design, Material, Physical, Por
Biocompatibility, and Performance Testing
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
January 7, 2014
Shandong Binxiang Medical Products Company, Limited Mr. Ray Zhou Official Correspondent 12390 East End Ave Chino, CA 91710
Re: K131832
Trade/Device Name: Shandong Binxiang Medical Products Company, Limited Powder-Free Vinyl Patient Examination Gloves, Non-Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Examination Gloves Regulatory Class: I Product Code: LYZ Dated: November 25, 2013 Received: December 2, 2013
Dear Mr. Zhou:
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 conceming your device in the Federal Register.
5
Page 2 - Mr. Zhou
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/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.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mary S. Runner -S
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: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) KI31832
Device Name
Shandong Binxiang Medical Products Co., Ltd. Powder-Free Vinyl Patient Examination Gloves, Non-Sterile
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 finger to prevent contamination between patient and examiner (21CFR 880.6250)
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)
Please do not write below this line – continue on a separate page if needed.
Image /page/6/Figure/12 description: The image shows a document with the heading "FOR FDA USE ONLY". It contains the text "Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)". The name "Sreekanth Gutala -S" is written on the document, along with a digital signature. The digital signature includes the date "2013.12.31 13:29:35 -05'00'".
FORM FDA 3881 (9/13)
利