(134 days)
Not Found
No
The device is a standard examination glove and the summary does not mention any AI or ML capabilities.
No
A therapeutic device is one that treats or prevents a disease or condition. This device, an examination glove, is intended to prevent contamination between patient and examiner, which is a protective measure, not a direct treatment or prevention of a medical condition for the patient.
No
Explanation: The device is an examination glove, which is intended to prevent contamination between patient and examiner. Its function is protective, not diagnostic.
No
The device description clearly identifies the device as a physical examination glove, which is a hardware medical device. The summary focuses on physical and chemical testing of the glove material, not software functionality.
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 hands or fingers to prevent contamination between patient and examiner. This is a physical barrier function, not a diagnostic test performed on a sample from the human body.
- Device Description: It's classified as a Class I device under 21 CFR 880.6250, which is for "Examination Vinyl Glove." This classification is for general and plastic surgery devices, not IVDs.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample from the human body (blood, urine, tissue, etc.).
- Providing information about a disease, condition, or state of health.
- Using reagents or other substances to perform a test.
The testing described focuses on the physical properties and safety of the glove as a barrier, not on its ability to diagnose anything.
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 fingers to prevent contamination between patient and examiner.(21 CFR 880.6250)
Product codes (comma separated list FDA assigned to the subject device)
LYZ
Device Description
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Examination Vinyl Glove, 80LYZ, and meets all requirements 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 fingers
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 Zibo Intco 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. AOL 2.5.
The FDA 1000 ml. Water Fill Test was also conducted with samplings of AOL 2.5, Inspection Level I, 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
510(K) SUMMARY
This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(K) number is: K132201
-
- Submitter's Identification: Zibo Intoo Medical Products, Co. Ltd. No. 18, Qingtian Road, Linzi District Oilu Chemical Industry Park Zibo City, Shandong Province China
Contact Person
John Zhao Tel: 909-548-4828, Fax: 909-548-4808 NOV 2 7 2013
Date summary prepared: Nov. 4, 2013
-
- Name of the Device:
Synmax Synthetic Examination Vinyl Gloves, Powder Free, Blue
- Name of the Device:
-
- Common Name: Synmax Synthetic Examination Vinyl Gloves, Powder Free, Blue
4. Predicate Device Information:
Shijiazhuang Eversharp Plastic Products Co., Ltd. Synthetic Powder Free (Yellow) Vinyl Examination Gloves (K011882)
-
- Device Description:
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Examination Vinyl Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06.
- Device Description:
-
- Intended 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.(21 CFR 880.6250)
- Intended Use:
7. Comparison to Predicate Devices:
Zibo Intco Medical Products, Co. Ltd.'s Synmax Synthetic Examination Vinyl Gloves, Powder Free, Blue is substantially equivalent in safety and effectiveness
1
to Shijiazhuang Eversharp Plastic Products Co., Ltd. Synthetic Powder Free (Yellow) Vinyl Examination Gloves (K011882). Please see table 7-2 for comparison details.
8. Discussion of Non-Clinical Test Performed for Determination of Substantial Equivalence are as Follows:
The standards used for Zibo Intco 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. AOL 2.5.
The FDA 1000 ml. Water Fill Test was also conducted with samplings of AOL 2.5, Inspection Level I, 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.
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).
9. 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 soap and water should be performed when appropriate.
10. Discussion of Clinical Tests Performed:
Not Applicable - There is no hypoallergenic Claim.
11. Conclusions:
Zibo Intco Medical Products, Co. Ltd. Synmax Synthetic Examination Vinyl Gloves, Powder Free, Blue, conform 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.
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| Proposed Device | Predicate Device (K051662) | |
|---|---|---|
| Description | Zibo Intco Medical Products, Co. Ltd. | |
| Synmax Synthetic Examination Vinyl | ||
| Gloves, Powder Free, Blue | Shijiazhuang Eversharp Plastic | |
| Products Co., Ltd. Synthetic | ||
| Powder Free (Yellow) Vinyl | ||
| Examination Gloves | ||
| (K011882) | ||
| Indication 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. | Substantially equivalent | |
| Labeling: Instruction | ||
| for use | A garment covering the hand and wrist | |
| area. That is a disposable device which | ||
| is worn upon the examiner's 'hands or | ||
| fingers to prevent contamination | ||
| between patient and examiner. | 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) and | ||
| Ultimate Elongations | Average Tensile Strength (Mpa): 14.4 | |
| Average Ultimate Elongations: 500% | Substantially equivalent | |
| Overall Length on | ||
| Medium Size | Average over 230mm | Substantially equivalent |
| Width of Palm on | ||
| Medium Size | Average 95mm | Substantially equivalent |
| Palm Thickness | Average 0.095 mm | Substantially equivalent |
| Figure Thickness | Average 0.090 mm | Substantially equivalent |
Table 7-2. Side-by-Side Comparison of Intended Use, Design, Material, Physical,
3
.
.
4
Image /page/4/Picture/0 description: The image shows the logo of the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 27, 2013
Zibo Intco Medical Products Company, Limited C/O Mr. John Zhao Official Correspondent Basic Medical Industries, Inc. 12390 East End Avenue CHINO CA 91710
Re: K132201
Trade/Device Name: Synthetic Examination Vinyl Gloves, Powder Free, Blue Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: October 28, 2013 Received: October 31, 2013
Dear Mr. Zhao:
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. Zhao
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,
Image /page/5/Picture/8 description: The image contains the text "Erin With". The text is in a bold, sans-serif font. The word "Erin" is clearly legible, while the word "With" is partially obscured by a decorative design.
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
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
Indications for Use
Form Approvad: OMB No. 0910-0120 Expiration Date: Docember 31, 2013 See PRA Statement on last page.
610(k) Number (if known) K 132201
Davice Name
Synroax Synthetis Examination Vinyl Oloves, Powder Free, Blue
Indications for Use (Describe)
A putiat coaznination between patant and comments of the more the is worn upon the exemitor's hands of fingers
to provent countinction between pation and examiner.(21 CFR 800
| 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)
| Elizabeth F. Claverie | S |
|---|---|
| 2013.11.26 01:19:15 -05'00' |
FORM FDA 3881 (9/13)
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