(93 days)
Not Found
No
The device is a disposable exam glove and the description and performance studies focus on physical and biological properties, with no mention of AI or ML.
No.
This device, an exam glove, is intended for preventing contamination between patient and examiner, not for treating or rehabilitating a medical condition.
No
The device is described as an exam glove, intended to prevent contamination between patient and examiner, with no indication of diagnostic function.
No
The device description clearly states it is a physical product (gloves) and the performance studies focus on physical and biological properties, not software performance.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Intended Use: The intended use of the Viny/Nitrile Blend Exam Glove is to be worn on the examiner's hands to prevent contamination between patient and examiner. This is a barrier device used for protection, not for analyzing biological specimens.
The description clearly indicates its function as a protective barrier during medical examinations, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Viny/Nitrile Blend Exam 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 (comma separated list FDA assigned to the subject device)
LYZ
Device Description
The subject device is powder free vinyl/nitrile blend examination gloves. The subject device is blue. 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
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 (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.
Summary of non-clinical performance testing:
ASTM D5250 Physical Dimensions Test:
Length(mm): S/M/L/XL: >=230; Results: >230/Pass;
Width(mm): S: 85+-5; Results: S: 82-88/Pass;
M: 95+-5; Results: M: 90-98/ Pass;
L: 105+-5; Results: L: 100-106/Pass;
XL: 115+-5; Results: XL:110-117/ Pass;
Thickness (mm): Finger: >=0.08, Palm: >=0.08; Results: Finger: 0.10-0.14/Pass, Palm: 0.08-0.10/Pass
ASTM D5151 Watertightness Test for Detection of Holes:
Acceptance Criteria: Meet the requirements of ASTM D5151 AQL 2.5; Results: 0/125/Pass
ASTM D6124 Powder Content:
Acceptance Criteria: Meet the requirements of ASTM D6124 =11MPa; Results: 13-25 MPa/Pass;
Ultimate Elongation: >=300%; Results: 302-586 %/Pass;
After Aging Tensile Strength: >=11MPa; Results: 11-23 MPa/Pass;
Ultimate Elongation: >=300%; Results: 308-462 %/Pass;
ISO 10993-5 Cytotoxicity:
Purpose: In Vitro Cytotoxicity; Results: Under conditions of the study, device extract is cytotoxic.
ISO 10993-11 Cytotoxicity:
Purpose: Non- acute systemic toxicity; Results: Under conditions of the study, did not show acute systemic toxicity in vivo / Pass
ISO 10993-10 Irritation:
Purpose: Non-irritating; Results: Under the conditions of the study, not an irritant/ Pass
ISO 10993-10 Sensitization:
Purpose: Non-sensitizing; Results: Under conditions of the study, not a sensitizer./ Pass
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
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.
February 18, 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: K213634
Trade/Device Name: Vinyl/Nitrile Blend Exam Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: November 11, 2021 Received: November 22, 2021
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.
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
1
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 medical devices and radiation-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,
Clarence W. Murray, III, PhD 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
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Indications for Use
510(k) Number (if known) K213634
Device Name Vinyl/Nitrile Blend Exam Glove
Indications for Use (Describe)
The Viny/Nitrile Blend Exam 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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3
510(k) Summary K213634
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: February 7, 2022
Designated Submission Correspondent
Mr. Boyle Wanq 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: | Vinyl/Nitrile Blend Exam Glove |
|---|---|
| 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: | Zibo Huiying Medical Products, Co. Ltd. |
|---|---|
| Device: | Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue |
| 510(k) number: | K153028 |
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5.0 Indication for Use
The Vinyl/Nitrile Blend Exam 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/nitrile blend examination gloves. The subject device is blue. 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
(K213634) | Predicated Device
(K153028) | Comparison |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Product Code | LYZ | LYZ | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Vinyl/Nitrile Blend
Exam Glove is a
disposable device
intended for medical
purposes that is worn on
the examiner's hands 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. | Same |
| Material | Poly Vinyl Chloride
Polyurethane
Nitrile
Di-(2-ethylhexyl)
Terephthalate(DOTP) | Poly Vinyl Chloride
Polyurethane
Diisononyl Phthalate
(DINP) | Similar
Analysis 1 |
| Powdered or
Powered free | Powdered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Colorant | Blue | Blue | Same |
| 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 |
Table1-General Comparison
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| Dimensions(mm) | Length: | Length: | Similar | |||
|---|---|---|---|---|---|---|
| S/M/L/XL: ≥230; | Average over 234 on M size | Analysis 2 | ||||
| Width: S: 85±5; | ||||||
| M: 95±5; | Width: | |||||
| Average over 96 on M size | ||||||
| L: 105±5; | ||||||
| XL: 115±5 | ||||||
| Thickness(mm) | Finger: ≥0.08; | Finger: Average 0.98; | Similar | |||
| Palm: ≥0.08 | Palm: Average 0.096 | Analysis 2 | ||||
| Physical | ||||||
| Properties | Before | |||||
| Aging | Tensile | |||||
| Strength | 11MPa, min | Tensile | ||||
| Strength | Average 16.9 MPa | Similar | ||||
| Analysis 3 | ||||||
| Ultimate | ||||||
| Elongation | 300% min | Ultimate | ||||
| Elongation | Average 550% | Similar | ||||
| Analysis 3 | ||||||
| Tensile | ||||||
| Strength | 11MPa, min | Tensile | ||||
| Strength | Average 14.4 MPa | Similar | ||||
| Analysis 3 | ||||||
| Ultimate | ||||||
| Elongation | 300%min | Ultimate | ||||
| Elongation | Average 550% | Similar | ||||
| Analysis 3 | ||||||
| After | ||||||
| Aging | Be free from holes when | |||||
| tested in accordance | ||||||
| with ASTMD5151 | ||||||
| AQL=2.5 | Be free from holes when | |||||
| tested in accordance | ||||||
| with ASTMD5151 | ||||||
| AQL=2.5 | Same | |||||
| Powder Content | Meet the requirements of | |||||
| ASTM D6124 | Meet the requirements of | |||||
| ASTM D6124 | ||||||
| Biocompatibility | ISO 10993-10; | |||||
| Under the conditions of | ||||||
| the study, not an irritant | ||||||
| or a sensitizer | Comply with | |||||
| ISO10993-10 | ||||||
| ISO 10993-11; | ||||||
| Under the condition of | ||||||
| acute | ||||||
| systemic toxicity test, | ||||||
| the test article did not | ||||||
| show acute systemic | ||||||
| toxicity in vivo. | ||||||
| ISO 10993-5 | ||||||
| Under conditions of the | ||||||
| study, device extract is | ||||||
| cytotoxic | / | / |
6
Analysis 1: The materials of the subject device are a little different with that of the predicate, but they all meet the performance requirements of ASTM D5250, also biocompatibility test has been performed on subject device and the test result can meet the requirements of ISO 10993 standards.
Analysis 2: The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D5250.
Analysis 3: The tensile strength and ultimate elongation are different with that of the predicate, but they all meet the requirements of ASTM D5250.
8.0 Summarv 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.
7
| Test
| Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM | |||
| D5250 | Physical | ||
| Dimensions | |||
| Test | Length(mm): | ||
| S/M/L/XL: ≥230; |
Width(mm):
S: 85±5;
M: 95±5;
L: 105±5;
XL: 115±5
Thickness (mm):
Finger: ≥0.08
Palm: ≥0.08 | Length(mm):
230/Pass;
Width(mm):
S: 82-88/Pass
M: 90-98/ Pass
L: 100-106/Pass
XL:110-117/ Pass
Thickness (mm):
Finger: 0.10-0.14/Pass
Palm: 0.08-0.10/Pass |
| 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