(89 days)
Not Found
No
The device is a patient examination glove, a simple barrier device with no mention of AI/ML in the description or performance studies.
No
The device, a patient examination glove, is intended to prevent contamination between patients and examiners, not to treat or cure a disease or condition.
No
This device, a patient examination glove, is intended to prevent contamination, not to diagnose a medical condition.
No
The device is a physical patient examination glove, not a software application. The description details material standards and physical testing, 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 is to prevent contamination between patients and examiners by being worn on the hands. This is a physical barrier function, not a diagnostic test performed on samples from the body.
- Device Description: It's classified as a Class I device under 21 CFR 880.6250, which covers patient examination gloves. 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 samples (blood, urine, tissue, etc.)
- Detecting specific substances or markers
- Providing diagnostic information about a patient's condition
The device is clearly described as a physical barrier for protection during patient examination.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiners' hands or fingers to prevent contamination between patients and examiners.
Product codes
LYZ
Device Description
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D-6139 and ASTM D-5250.
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
examiners / Not Found
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
The standards used for Anhui Intco Medical Products Co, Itd.'s gloves product are based on ASTM D-6319 and ASTM D-5250. 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 based on ASTM-D5151-06 was also conducted samplings of AQL 2.5 inspection level G-1. meeting these requirements. Primary Skin Irritation and Skin Sensitization testing was conducted with results showing no primary skin irritant or sensitization reactions.
A Residual Powder Test that based on ASTM D-6124 for start to finish inspection is conducted to ensure that our gloves meet our "powder-free" claims (contains no more than 2 mg powder per glove).
Key Metrics
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 22, 2019
Anhui Intco Medical Products Co. Ltd % Derek Tian Official Correspondent Intco Medical Industries, Inc. 805 Barrington Ave Ontario. California 91764
Re: K191092
Trade/Device Name: Powder-Free Vinyl Patient Examination Gloves, Yellow Color Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: April 16, 2019 Received: April 24, 2019
Dear Derek Tian:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K191092
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 examiners' hands or fingers to prevent contamination between patients and examiners
| 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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3
Anhui Intco Medical Products Co,ltd
No. 1 Haitang Road, Suixi District economic development area, Huaibei City, Anhui Province
510(K) SUMMARY
This summary of 510(K) is being submitted in accordance with 21 CFR §807.92.
1. Submitter's Identification:
Anhui Intco Medical Products Co, Itd. No.1 Haitang Road, Suixi District economic development area Huaibei City, Anhui Province China
Contact Person
Jacken Cai Tel: 86-13853653818
Date summary prepared: July 17, 2019
2. Name of the Device: Powder-free Vinyl Patient Examination Gloves, Yellow Color
3. Common Name:
Non-powdered patient examination glove
4. Predicate Device Information:
Device name: Vinyl Examination Gloves, Powder-Free, Yellow 510(K) #: K022091 Manufacturer name: Tangshan Zhonghong Pulin Food Products Co., Ltd
5. Device Description:
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D-6139 and ASTM D-5250.
4
6. Intended Use:
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiners' hands or fingers to prevent contamination between patients and examiners.
| | Subject Device
(K191092) | Predicate Device
(K022091) | Comparison |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Description | Powder-free Vinyl Patient
Examination Gloves, Yellow
Color by Anhui Intco Medical
Products Co, ltd. | Vinyl Examination Gloves,
Powder-Free, Yellow by
Tangshan Zhonghong Pulin
Food Products Co.,
Ltd. | Similar |
| Indication for use | A patient examination glove is
a disposable device intended
for medical purposes that is
worn upon the examiners'
hands or fingers to prevent
contamination between patients
and examiners. | A patient examination glove is
a disposable device intended
for medical purposes that is
worn upon the examiners'
hands or fingers to prevent
contamination between
patients and
examiners. | Same |
| Labeling: Labels
on the carton | Labels include: Product name;
color; "single use Only" size,
piece count, lot number,
distributor name , and
manufacturer address. | Labels include: Product
name; color; "single use Only"
size, piece count, lot number,
distributor name, and
manufacturer address. | Same |
| Device Materials | Poly Vinyl Chloride | Poly Vinyl Chloride | Same |
| Before Aging:
Tensile
Strength(Mpa) and
Ultimate
Elongations | Average Tensile
Strength (Mpa): 17.44
Average Ultimate Elongations:
519.4% | Average Tensile
Strength (Mpa): 17.00
Average Ultimate
Elongations: 500% | Similar |
| After Aging:
Tensile
Strength(Mpa) and
Ultimate
Elongations | Average Tensile
Strength (Mpa): 15
Average Ultimate Elongations:
481.96% | Average Tensile
Strength (Mpa): 15 Average
Ultimate
Elongations: 475% | Similar |
| Overall Length on
Medium Size | Average over 232.23mm | Average over 230.00 mm | Similar |
| Width of Palm on
Medium Size | Average 95.08mm | Average 95.00mm | Same |
| Palm Thickness | Average 0.095 mm | Average 0.095 mm | Same |
| Figure Thickness | Average 0.090 mm | Average 0.090 mm | Similar |
| Residual Powder | According to ASTM D6124-06
Standard Test Method for
Residual Powder on Medical
gloves for the determination of
| According to ASTM D6124-06
Standard Test Method for
Residual Powder on Medical
gloves for the determination of
residual powder content.
Testing result indicates the
weight of all types of residual or
powder on finished powder-free
gloves as