(108 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of examination gloves, with no mention of AI or ML technology.
No
The device, a disposable examination glove, is intended to prevent contamination and is not designed to treat, cure, mitigate, or prevent disease.
No
Explanation: A diagnostic device is used to detect, diagnose, or monitor a medical condition. The provided text clearly states the device is a "non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner," indicating its primary function is barrier protection, not diagnosis. The performance studies and key metrics also focus on physical and chemical properties of the gloves, not diagnostic accuracy.
No
The device is a physical product (nitrile gloves) and the description focuses on its material properties and physical performance characteristics, 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 patient and examiner." This is a barrier function, not a diagnostic function. IVDs are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description focuses on the physical properties of the glove as a barrier (nitrile films, water tight, tensile properties). It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD-related information: The document does not mention any of the typical elements associated with IVDs, such as:
- Analysis of biological specimens (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnostic claims
- Reagents or assays
The device is clearly described as a medical device intended for barrier protection during medical examinations.
N/A
Intended Use / Indications for Use
Nitrile disposable examination gloves are non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
Nitrile films form a barrier to prevent contamination between patient and examiner.
The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.
The Nitrile glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (medical purposes)
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 following bench testing was conducted for design elements and performance characteristics deemed appropriate to demonstrate conformance with the applicable standards. The non-clinical performance testing completed for the XINGYU MEDICAL TECH CO.,LTD. nitrile disposable examination gloves demonstrated that the subject device met the acceptance criteria or specification for the applicable test methodology or standard as shown below.
- . Dimension per ASTM D6319-19
- . Tensile strength (Before aging/ After aging) and Elongated rate (Before aging/ After aging) per ASTM D6319-19
- Water leak test on pinhole per ASTM D6319-19/D6124-06 (2017)
- Powder Residual tests per ASTM D6319-19
- . Biocompatibility tests per ISO 10993-10: 2010 and ISO 10993-11: 2017
Clinical data is not needed to demonstrate the performance or safety of the subject glove as compared to the predicate device or applicable standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Dimensions:
- Length: ≥220 mm (S), ≥230 mm (M, L, XL) - Pass
- Width: S: 80±10 mm, M: 95±10 mm, L: 110±10 mm, XL: 120±10 mm - Pass
- Thickness Finger: ≥0.05 mm - Pass
- Thickness Palm: ≥0.05 mm - Pass
- Physical properties (ASTM D6319-19):
- Before Aging: Tensile ≥14 Mpa; Elongation ≥ 500% - Pass
- After Aging: Tensile ≥14 Mpa; Elongation ≥ 400% - Pass
- Watertightness Test (ASTM D6319-19/ASTM D5151-19):
- Batch size=35000, sample 125, ≤ 7 defectives - Pass
- Powder Residual (ASTM D6319-19/D6124-06(2017)):
- ≤ 2 (mg/glove) - Pass
- Biocompatibility:
- Skin Irritation Test (ISO 10993-10: 2010): non-irritation - Passes, subject device is non-irritation.
- Skin sensitization (ISO 10993-10: 2010): non-sensitization - Passes, subject device is non-sensitization.
- Acute Systemic Toxicity Test (ISO 10993-11: 2017): non-acute systemic toxicity - Passes, subject device is non-acute systemic toxicity.
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.
December 2, 2021
Xingyu Medical Tech Co., Ltd. Eva Li Consultant Shanghai Sungo Management Consulting Company Limited Room 1309, Dongfang Building, 1500# Century Ave Shanghai, Shanghai 200122 China
Re: K212578
Trade/Device Name: Nitrile disposable examination gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: October 24, 2021 Received: November 3, 2021
Dear Eva Li:
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
542 of the Act); 21 CFR 1000-1050.
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-
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.
Ligun Zr
For 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) K212578
Device Name Nitrile disposable examination gloves
Indications for Use (Describe)
Nitrile disposable examination gloves are non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger 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
K212578(Page1 / 5)
NO.2189 YAOQIAN ROAD, GAOMI ECONOMIC DEVELOPMENT ZONE, WEIFANG CITY, SHANDONG PROVINCE,
CHINA
510 (K) Summary
The assigned 510(k) number is: K212578
Premarket Notification [510(k)] Summary
1.0 Submitter:
| Submitter's name : | XINGYU MEDICAL TECH CO.,LTD. |
|---|---|
| Submitter's Address : | NO.2189 YAOQIAN ROAD, GAOMI ECONOMIC DEVELOPMENT ZONE, |
| WEIFANG CITY, SHANDONG PROVINCE, CHINA | |
| Phone number : | 0086-18263618867 |
| Contact person: | Cathrine Luan |
| Email: | cathrine@xingyugloves.com |
Submission Correspondent Primary contact: Ms. Eva Li Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: eatereva@hotmail.com
Secondary contact: Mr. Raymond Luo Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
Date of Preparation: 2021-11-23
2.0 Name of the Device
Proprietary/Trade name: Nitrile disposable examination gloves Model(s):
| Model | Color | Size |
|---|---|---|
| D5000 | Blue | S, M, L, XL |
| D6000 | Black | S, M, L, XL |
| D7000 | White | S, M, L, XL |
| D8000 | Purple | S, M, L, XL |
| Common Name: | Exam gloves |
| Common Name: | Exam gloves |
|---|---|
| Classification Name: | Patient examination glove |
| Device Classification: | Class I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital |
| Product Code: | LZA |
4
NO.2189 YAOQIAN ROAD, GAOMI ECONOMIC DEVELOPMENT ZONE, WEIFANG CITY, SHANDONG PROVINCE,
CHINA
3.0 Predicate Device
| Device Name: | Xingyu Powder Free Nitrile Patient Examination Gloves, Blue Color |
|---|---|
| Company name: | Shandong Xingyu Gloves Co.,Ltd. |
| 510(K) Number: | K171616 |
4.0 Device Description:
How the device functions:
Nitrile films form a barrier to prevent contamination between patient and examiner. Scientific concepts that form the basis for the device:
The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.
Physical and performance characteristics such as design, materials and physical properties: The Nitrile glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151.
5.0 Device Indication for use:
Nitrile disposable examination gloves are non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
| Features &
Description | Predicate Device | Proposed Device | Result of
Comparison |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Company | Shandong Xingyu Gloves
Co.,Ltd | XINGYU MEDICAL TECH
CO.,LTD. | – |
| 510(K) Number | K171616 | K212578 | – |
| Product name | Xingyu Powder Free Nitrile
Patient Examination Gloves,
Blue | Nitrile disposable
examination gloves | – |
| Product Code | LZA | LZA | Same |
| Size | Small/ Medium/ Large/X large | Small/Medium/Large/X large | Same |
| Indications for Use | Powder Free Nitrile Patient
Examination Gloves, Blue
Color 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. | Nitrile disposable
examination gloves are non-
sterile disposable device
intended for medical
purposes that is worn on the
examiner's hand or finger to
prevent contamination
between patient and
examiner. | Same |
6.0 Summary of the Technological Characteristics of the Device:
5
K212578(Page3 / 5)
NO.2189 YAOQIAN ROAD, GAOMI ECONOMIC DEVELOPMENT ZONE, WEIFANG CITY, SHANDONG PROVINCE,
CHINA
| Device Description
and Specifications | Meets ASTM D6319-10
(Reapproved 2015) | Meets ASTM D6319-19 | same |
|----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Dimensions
Length
ILS-2 AQL4.0 | 232 mm min for all sizes | 230 mm min for all size | Similar1 |
| Dimensions --
Width
IL S-2 AQL4.0 | S: 76-88 mm
M: 89-102 mm
L: 108-119mm
XL: 115-128 mm | S: 83-89 mm
M: 88-100 mm
L: 103-111 mm
XL: 114-119 mm | Similar1 |
| Dimensions --
Thickness IL S-2
AQL4.0 | Thickness (mm) min. Finger
0.08
Palm 0.08 | Thickness (mm) min. Finger
0.09
Palm 0.05 | Similar1 |
| Physical Properties
IL S- 2 AQL4.0 | Aging
Elongation (%)
Tensile
Strength
(MPa) | Aging
Elongation (%)
Tensile
Strength
(MPa) | Similar2 |
| | Before After
530- 460-
600 580
18-25 17-22 | Before After
≥500% ≥400%
≥14 ≥14 | |
| Freedom from
Pinholes
Inspection Level I
AQL2.5 | Meets
• 21 CFR 800.20
• ASTM D6319-10 (Reapproved
2015) Tested in accordance
with ASTM D5151
(Reapproved 2015)
with acceptable results | Meets
•ASTM D 6319-19 Tested in
accordance with ASTM
D5151-19 with acceptable
results | same |
| Residual Powder | Meets ASTM D 6124-06
(Reaffirmation 2011)
Results generated values
below 2mg of residual
powder | Meets ASTM D 6124-06 (2017)
Results generated values
below 2mg of residual
powder | same |
| Materials used to
fabricate the devices | Nitrile | Nitrile | same |
| Shelf life | NA | 3 years | Different1 |
| Compare data
supporting Device
Performance | Meets ASTM D5151-06
(Reapproved 2015) ASTM
D6319-10 (Reapproved 2015)
ASTM D6124-06
(Reaffirmation 2011) | Meets ASTM D5151-
19 ASTM D6319-19
ASTM D6124-06(2017) | same |
| Single Patient Use | Single Patient Use | Single Patient Use | same |
| Biocompatibility | Under the conditions of this
study, the test article was a
non-irritant or non-sensitizer.
Meets ISO 10993-10:2010 | Under the conditions of this
study, the test article was a non-
irritant, non- sensitizer and does
not pose acute systemic toxicity.
Meets ISO 10993-10:2010.
Meets ISO 10993-11:2017 | Similar3 |
6
K212578(Page4 / 5)
NO.2189 YAOQIAN ROAD, GAOMI ECONOMIC DEVELOPMENT ZONE, WEIFANG CITY, SHANDONG PROVINCE,
CHINA
Similar*1 analysis :
The Dimensions (length, width and fingers thickness) of the proposed deice is not same with the predicate device, however the Dimensions of the subject device all meet the criteria of the ASTM D6319-19. The test results show the differences do not affect compliance with the associated standards for the proposed device.
Similar*2 analysis :
Physical Properties of the proposed deice is not same with the predicate device, however the Physical Properties meet the criteria of the ASTM D6319-19. The test results show the differences do not affect compliance with the associated standards for the proposed device.
Similar*3 analysis :
Compare the predicate device, except the Skin Irritation Test and Skin sensitization test, the proposed device conduct the Acute Systemic Toxicity Test meets ISO 10993-11: 2017 additional and show it non-acute systemic toxicity. The biocompatibility test results show the differences do not affect compliance with the associated standards for the proposed device.
Different*1 analysis :
The proposed device determined with a 3 year shelf life. This shelf life determination was conducted under experiment per ASTM D7161-16. The observed differences do not affect compliance with the associated standards for the proposed device.
7.0 Assessment of Non-Clinical Performance Data:
The following bench testing was conducted for design elements and performance characteristics deemed appropriate to demonstrate conformance with the applicable standards. The non-clinical performance testing completed for the XINGYU MEDICAL TECH CO.,LTD. nitrile disposable examination gloves demonstrated that the subject device met the acceptance criteria or specification for the applicable test methodology or standard as shown below.
- . Dimension per ASTM D6319-19
- . Tensile strength (Before aging/ After aging) and Elongated rate (Before aging/ After aging) per ASTM D6319-19
- Water leak test on pinhole per ASTM D6319-19/D6124-06 (2017)
- Powder Residual tests per ASTM D6319-19
- . Biocompatibility tests per ISO 10993-10: 2010 and ISO 10993-11: 2017
Performance of the nitrile disposable examination gloves are tested with the following technological characteristics as compared to ASTM or equivalent standards.
| Test
| methodology | Purpose | Acceptance criteria | Result | ||||
|---|---|---|---|---|---|---|---|
| S | M | L | XL | ||||
| ASTM D6319-19 | Physical | ||||||
| Dimensions | Length ( mm ) | ≥220 | ≥230 | pass | |||
| Width ( mm ) ±10 | 80±10 | 95±10 | 110±10 | 120±10 | pass | ||
| Thickness Finger | ≥0.05 mm | pass | |||||
| Palm | ≥0.05 mm | pass | |||||
| ASTM D6319-19 | Physical | ||||||
| properties | Before Aging | Tensile≥14Mpa; Elongation ≥ 500% | pass | ||||
| After Aging | Tensile≥14Mpa; Elongation ≥ 400% | pass |
7
K212578(Page5 / 5)
NO.2189 YAOQIAN ROAD, GAOMI ECONOMIC DEVELOPMENT ZONE, WEIFANG CITY, SHANDONG PROVINCE,
| CHINA | |
|---|---|
| -- | ------- |
| ASTM D6319-19
Test method in
accordance with
ASTM D5151-19 | Watertight
ness Test
for
detection
of holes | Batch size=35000, sample 125
$≤$ 7 | pass |
|-----------------------------------------------------------------------------------|---------------------------------------------------------|---------------------------------------|------|
| ASTM standard
D 6319-19
Test method in
accordance with
D6124-06(2017) | Powder
Residual | $≤$ 2 (mg/glove) | pass |
| Purpose | Standard | Acceptance
criteria | Result |
|------------------|--------------------------------------------------------------------------|---------------------------------|---------------------------------------------------------------------------------------------------------|
| Biocompatibility | Skin Irritation Test Extraction
Method ISO 10993-10: 2010 | non-irritation | Passes
Under the conditions of
the study, the subject
device is non-
irritation |
| Biocompatibility | Skin sensitization the guinea
pig maximization ISO 10993-
10: 2010 | non- sensitization | Passes
Under the conditions of
the study, the subject
device is non-sensitization |
| Biocompatibility | Acute Systemic Toxicity
Test ISO 10993-11: 2017 | non- acute systemic
toxicity | Passes
Under the conditions of
the study, the subject
device is non-acute
systemic toxicity |
8.0 Assessment of Clinical Performance Data:
Clinical data is not needed to demonstrate the performance or safety of the subject glove as compared to the predicate device or applicable standards.
9.0 Conclusion:
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k) submission K212578, the Nitrile disposable examination gloves, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K171616.