(109 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of examination gloves, with no mention of AI or ML.
No
The device is described as an examination glove intended to prevent contamination, not to treat or diagnose a disease or condition.
No
Explanation: The device is a patient examination glove, described as a disposable device worn on the hands to prevent contamination. Its purpose is protective, not diagnostic.
No
The device description clearly states it is a physical product (examination gloves) and the performance studies focus on physical and biological properties, 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 clearly stated as a "disposable device intended for medical purposes that is worn upon the examiner's hands to prevent contamination between patient and examiner." This describes a barrier device for infection control, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description details a physical barrier (gloves) made of vinyl and nitrile. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing specimens, reagents, calibrators, controls, or any other elements typically associated with in vitro diagnostics.
- Performance Studies: The performance studies focus on physical properties (dimensions, watertightness, tensile strength, elongation) and biocompatibility (cytotoxicity, irritation, sensitization), which are relevant for a barrier device, not an IVD.
- Predicate Device: The predicate device is also described as "Patient Examination Vinyl Gloves," further supporting its classification as a barrier device.
In summary, the device's purpose is to provide a physical barrier during patient examinations, which falls under the category of medical devices for infection control, not in vitro diagnostics.
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 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 examination gloves, adding 1%-3% nitrile to improve the tensile strength and ultimate elongation. The subject device is blue color. 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
Not Found
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 10993-10:2010, ISO 10993-11:2017, ASTM D6124-06 (Reapproved 2017), ASTM D5151-19, ASTM D5250-19. Key results include:
- Physical Dimensions Test (ASTM D5250) showed compliance for length, width (S, M, L, XL sizes), and thickness (finger and palm).
- Watertightness Test for Detection of Holes (ASTM D5151) showed 0/125/Pass.
- Powder Content (ASTM D6124) showed 0.14mg/Pass.
- Physical properties (ASTM D412) met tensile strength and ultimate elongation requirements both before and after aging.
- Biocompatibility tests (ISO 10993-11, ISO 10993-10) showed no acute systemic toxicity, no irritation, and no sensitization.
Clinical testing is not needed for this device.
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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 26, 2021
Shandong Hongxin Chemicals Co.,Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801, No.161, East Lujiazui Rd., Pudong Shanghai, Shanghai 200120 China
Re: K212488
Trade/Device Name: Synthetic Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: October 18, 2021 Received: October 29, 2021
Dear Mr. 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 and Part 809); 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
2
Indications for Use
510(k) Number (if known) K212488
Device Name Synthetic Nitrile Examination Gloves
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands to prevent contamination between patient and examiner.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Registration Use (Part 21 CFR 201.66) Select One | Service Use Correction (21 CFR 201.66) Select One | ||
|---|---|---|---|
| ------------- | -------------------------------------------------- | ------------- | --------------------------------------------------- |
__ 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 (K212448)
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Name: Shandong Hongxin Chemicals Co.,Ltd. Address: No.10161, Xinhua Road, Zhoucun District, Zibo City, Shandong Province, China 255300 Tel: +86-15550323002 Contact: Ping Wang
Designated Submission Correspondent
Name: Shanghai Truthful Information Technology Co., Ltd. Address: Room 1801, No. 161 East Lujiazui Rd., Pudong,Shanghai 200120 ,China Tel: +86-21-50313932 Contact: Mr. Boyle Wang Email: Info@truthful.com.cn
Date of Preparation: Oct.18th,2021
2.0 Device Information
Trade name: Synthetic Nitrile Examination Gloves Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): S, M, L, XL Production code: LYZ Regulation number: 21CFR880.6250 Classification: Class I General Hospital Panel:
3.0 Predicate Device Information
Manufacturer: Zibo Huiying Medical Products, Co. Ltd. Synmax Synthetic Patient Examination Vinyl Gloves,Powder Free,Blue Device: 510(k) number: K153028
4.0 Indication for Use
4
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands to prevent contamination between patient and examiner.
5.0 Device Description
The subject device is powder free vinyl examination gloves, adding 1%-3% nitrile to improve the tensile strength and ultimate elongation. The subject device is blue color. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
6.0 Technological Characteristic Comparison Table
| Item | Subject Device
(K212448) | Predicate Device
(K153028) |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | LZA | LZA |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 |
| Class | I | I |
| Intended Use | A patient examination glove is a disposable device intended for medical purposes that is worn upon 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 to prevent contamination between patient and examiner. |
| Material | Poly Vinyl Chloride
Polyurethane
Nitrile
Di-(2-ethylhexyl)
Terephthalate(DOTP) | Poly Vinyl Chloride
Polyurethane
Diisononyl Phthalate (DINP) |
| Powdered or
Powered free | Powdered free | Powdered free |
| Design Feature | Ambidextrous | Ambidextrous |
| Colorant | Blue | Blue |
| 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 |
| Dimensions(mm) | Length:
≥230;
Width: | Length:
Average over 234 on M size;
Width: |
Table1-General Comparison
5
| S: 85±5;
M: 95±5;
L: 105±5;
| XL: 115±5 | Average over 96 on M size | ||||
|---|---|---|---|---|---|
| Thickness(mm) | Finger: ≥0.08; | ||||
| Palm: ≥0.08 | Finger: Average 0.98; | ||||
| Palm: Average 0.096 | |||||
| Physical | |||||
| Properties | Before | ||||
| Aging | Tensile | ||||
| Strength | 11MPa, min | Tensile | |||
| Strength | Average 16.9MPa | ||||
| Ultimate | |||||
| Elongation | 300% min | Ultimate | |||
| Elongation | Average 550% | ||||
| After | |||||
| Aging | Tensile | ||||
| Strength | 11MPa, min | Tensile | |||
| Strength | Average 14.4MPa | ||||
| Ultimate | |||||
| Elongation | 300%min | Ultimate | |||
| Elongation | Average 500% | ||||
| 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=2.5 | |||||
| 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 | ISO 10993-10; | ||||
| Under the conditions of the | |||||
| study, not an irritant or a | |||||
| sensitizer | |||||
| 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 | / |
7.0 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 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
6
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 | ||||
| D5250 | Physical | |||
| Dimensions | ||||
| Test | Length(mm): | |||
| $\ge$ 230; | Length: |
240/Pass; | |
| | | Width(mm):
S: 85±5;
M: 95±5;
L: 105±5;
XL: 115±5 | Width:
S: 87-88 /Pass
M: 96-98/ Pass
L: 105-107/ Pass
XL:116/Pass | |
| | | Thickness (mm): | | |
| | | Finger: $\ge$ 0.08 | Finger: 0.12-0.13/Pass | |
| | | Palm: $\ge$ 0.08 | Palm: 0.08-0.09/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