(231 days)
Not Found
No
The 510(k) summary describes a standard vinyl examination glove and does not mention any AI or ML capabilities. The performance studies focus on physical and biological properties, not algorithmic performance.
No
The device, a vinyl examination glove, is solely intended to prevent contamination between patient and examiner. It does not provide any therapeutic benefit or treatment.
No
The device description clearly states it is a "Vinyl Examination Glove" intended to prevent contamination between patient and examiner, which is a barrier function, not a diagnostic one. No diagnostic claims, measurements, or outputs are associated with the device.
No
The device is a physical examination glove, not a software application. The description focuses on material properties and physical tests, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is "worn on the examiner's hands to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function.
- Device Description: The description is for a physical barrier (a glove) and doesn't involve any components or processes related to testing samples from the body (like blood, urine, tissue, etc.) to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing information for diagnosis.
- Performance Studies: The performance studies focus on the physical properties and biocompatibility of the glove, not on diagnostic accuracy or performance.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. This device is a physical barrier used during medical examinations.
N/A
Intended Use / Indications for Use
The Vinyl Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
Product codes
LYZ
Device Description
The subject device is powder free vinyl examination gloves. The subject device's color is yellow. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
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)
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
ISO 10993-5 Third edition 2009-06-01, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
ISO 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves
ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D5250-19, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Non-clinical performance testing results:
Physical Dimensions Test (ASTM D6319):
Length(mm): > 230/Pass
Width(mm): S: 83-85 /Pass; M: 94-96/ Pass; L: 103-106/ Pass; XL:113-115/ Pass
Thickness (mm): Finger: 0.11-0.12/Pass; Palm: 0.09-0.10/Pass
Watertightness Test for Detection of Holes (ASTM D5151): 0/125/Pass
Powder Content (ASTM D6124): 0.11-0.14mg/Pass
Physical properties (ASTM D412):
Before Aging: Tensile Strength 17.3-23.6MPa/Pass; Ultimate Elongation 315.7-410.2%/Pass
After Aging: Tensile Strength 13.1-21.0MPa/Pass; Ultimate Elongation 309.2-367.4%/Pass
Cytotoxicity (ISO 10993-5): Under conditions of the study, device extract is cytotoxic.
Cytotoxicity (ISO 10993-11): Under conditions of the study, did not show acute systemic toxicity in vivo / Pass
Irritation (ISO 10993-10): Under the conditions of the study, not an irritant/ Pass
Sensitization (ISO 10993-10): Under conditions of the study, not a sensitizer / Pass
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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 25, 2022
Dezhou Hengchang Medical Technology Co., Ltd % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161 Lujiazui East Rd.,Pudong Shanghai, Shanghai 200120 China
Re: K220055
Trade/Device Name: Disposable, vinyl examination gloves, Yellow Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: August 12, 2022 Received: August 16, 2022
Dear Boyle Wang:
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.
1
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.
Bifeng Qian, M.D., Ph.D. Assistant Director 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) K220055
Device Name Disposable, vinyl examination gloves, Yellow
Indications for Use (Describe)
The Vinyl Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
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)
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510(k) Summary K220055
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Name: Dezhou Hengchang Medical Technology Co., Ltd. Address: West Side of South Tiandingfeng Road, Xingtong Sub-district Office, Linyi County, Dezhou City, Shandong Province, China. Phone Number: +86 15963319855 Contact: Jing Li Date of Preparation: Aug.12, 2012
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong,Shanghai 200120 ,China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
Trade name: Disposable, vinyl examination gloves, Yellow Common name: Vinyl Patient Examination Glove Classification name: Non-powdered patient examination glove Model(s): S, M, L, XL
3.0 Classification
Production code: LYZ Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital
4.0 Predicate Device Information
Manufacturer: ZHICHENG TRADING CO., LTD. Device: Vinyl Examination Glove (Clear, Non-Colored) 510(k) number: K180861
4
5.0 Indication for Use
The Vinyl Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
6.0 Device Description
The subject device is powder free vinyl examination gloves. The subject device's color is yellow. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
7.0 Technological Characteristic Comparison Table
| Item | Subject Device
(K220055) | Predicated Device
(K180861) | Remark |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Product Code | LYZ | LYZ | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Vinyl Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. | The Vinyl Examination Glove (Clear, Non-Colored) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. | Same |
| Material | Vinyl | Vinyl | Same |
| Powdered or
Powered free | Powdered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Colorant | Yelow | Clear | Different
Analysis 1 |
| Labeling
Information | Single-use indication, powder free, device color, device name, glove size and quantity, Non-Sterile | Single-use indication, powder free, device color, device name, glove size and quantity, Non-Sterile | Same |
| Dimensions(mm) | Length:
S/M/L/XL: ≥230;
Width: | Length:
S≥230;
M≥235; | Similar
Analysis 1 |
Table1-General Comparison
5
| | | S: 85±5;
M: 95±5;
L: 105±5;
XL: 115±5 | L≥245;
XL≥245;
Width:
S: 85±5;
M: 95±5;
L: 105±5;
XL: 115±5 | | | |
|----------------------------|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|------------|--------------------|
| | Thickness(mm) | Finger: ≥0.08;
Palm: ≥0.08 | Finger: ≥0.05;
Palm: ≥0.08 | Similar Analysis 1 | | |
| | | | | | | |
| Physical
Properti
es | Befor
e
Aging | Tensile
Strength | 11MPa, min | Tensile
Strength | 15MPa, min | Similar Analysis 2 |
| | | Ultimate
Elongation | 300% min | Ultimate
Elongation | 380% min | Similar Analysis 2 |
| | After
Aging | Tensile
Strength | 11MPa, min | Tensile
Strength | 15MPa, min | Similar Analysis 2 |
| | | Ultimate
Elongation | 300%min | Ultimate
Elongation | 380%min | Similar Analysis 2 |
| Freedom from
Holes | | Be free from holes when
tested in accordance with
ASTMD5151
AQL=2.5 | | Be free from holes when
tested in accordance with
ASTMD5151
AQL=1.5 | | Similar Analysis 3 |
| Powder Content | | Meet the requirements of
ASTM D6124 | | Meet the requirements of
ASTM D6124 | | Same |
| Biocompatibility | | ISO 10993-10;
Under the conditions of
the study, not an irritant
or a sensitizer | | Comply with
ISO10993-10 | | Same |
| | | ISO 10993-5
Under conditions of the
study, device extract is
cytotoxic | | Under conditions of the
study, did not show
potential toxicity to L-929
cells. Complies with ISO
10993-5 | | / |
| | | ISO 10993-11;
Under the
condition of acute
systemic toxicity test,
the test article did not
show acute systemic
toxicity in vivo | | / | | / |
Analysis 1: The color and physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D5250, so the differences do not raise any new safety or performance questions.
6
Analysis 2: The tensile strength and ultimate elongation are different with that of the predicate, but they all meet the requirements of ASTM D5250, so the differences do not raise any new safety or performance questions.
Analysis 3: Freedom from holes of subject device is similar with that of the predicate, but they all meet the requirements of ASTMD5151, so the differences do not raise any new safety or performance questions.
8.0 Summary of Non-clinical Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
ISO 10993-5 Third edition 2009-06-01, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
ISO 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests
for systemic toxicity.
ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves
ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D5250-19, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.
| Test
| Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM | |||
| D6319 | Physical | ||
| Dimensions | |||
| Test | Length(mm): | ||
| S/M/L/XL: ≥230; | Length(mm): |
230/Pass; |
| | | Width(mm):
S: 85±5;
M: 95±5;
L: 105±5;
XL: 115±5 | Width(mm):
S: 83-85 /Pass
M: 94-96/ Pass
L: 103-106/ Pass
XL:113-115/ Pass |
| | | Thickness (mm):
Finger: ≥0.08
Palm: ≥0.08 | Thickness (mm):
Finger: 0.11-0.12/Pass
Palm: 0.09-0.10/Pass |
Table 2 - Summary of non-clinical performance testing
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| ASTM
D5151 | Watertightness
Test
for
Detection of
Holes | Meet the requirements of ASTM D5151
AQL 2.5 | | 0/125/Pass | |
|-----------------|--------------------------------------------------------|------------------------------------------------|------------------------|---------------------------------------------------------------------------------------------|--------------------|
| ASTM
D6124 | Powder
Content | Meet the requirements of ASTM D6124