(87 days)
Not Found
No
The device description and performance studies focus solely on the physical and material properties of examination gloves, with no mention of AI or ML technologies.
No
The device, examination gloves, is intended to prevent contamination between patient and examiner, which is a barrier function, not a therapeutic one. It does not treat or cure any medical condition.
No.
The document explicitly states that the device is a "Nitrile Patient Examination Glove" and is intended for "prevent[ing] contamination between patient and examiner." Its function is barrier protection, not diagnostic analysis or assessment of a medical condition.
No
The device description clearly states it is a physical glove made of nitrile, which is a hardware component. There is no mention of any software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gloves are "worn on the examiner's hands or finger to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function performed on samples taken from the body.
- Device Description: The description focuses on the physical properties and material of the glove, not on any reagents, instruments, or procedures used to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
- Reagents, calibrators, or controls
The device is a medical device, specifically a Class I medical device (examination glove), but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Nitrile Patient Examination Gloves are non-sterile disposable devices intended for medical purposes that are worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
The subject device is powder free nitrile examination gloves. The glove is manufactured from nitrile. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand. The subject device is blue. The subject device is non-sterile, and single use device to prevent contamination between patient and examiner. The subject device can be available in six specifications: XS, S, M, L, XL and XXL.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands or finger
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 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity 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 D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. Key results include: Length: >230 (Pass), Width: XS: 78-80, S: 86-89, M: 97-99, L: 117-119, XL: 116-118, XXL:128-131 (Pass), Thickness (Finger: 0.08-0.13, Palm: 0.07-0.11 across sizes - Pass), Watertightness Test for Detection of Holes (2/125,0/125,0/125,1/125,0/125,0/125 leaks - Pass), Powder Content (0.05,0.06,0.08,0.07,0.09,0.06 - Pass), Physical properties Before Aging (Tensile Strength ≥14MPa; Ultimate Elongation ≥500% - Pass for all sizes), Physical properties After Aging (Tensile Strength ≥14MPa; Ultimate Elongation ≥400% - Pass for all sizes), Cytotoxicity (Non-cytotoxic - Pass), Irritation (Non-irritating - Pass), Sensitization (Non-sensitizing - 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 shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.
August 11, 2021
Zhangjiagang Huayuan Protective Equipment 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: K211434
Trade/Device Name: Nitrile Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA
Dear Boyle Wang:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated August 5, 2021. Specifically, FDA is updating this SE Letter as an administrative correction for the company's name.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Clarence W. Murray III, Assistant Director of Office of Surgical and Infection Control Devices, at Tel: 301 -796 - 0270 or Email: Clarence.Murray@fda.hhs.gov.
Sincerely,
Liqun Zhao -S
For Clarence W. Murray III, 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
1
Image /page/1/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. The logos are simple and professional in appearance.
August 5, 2021
Zhangjiagang Huayan Protective Equipment 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: K211434
Trade/Device Name: Nitrile Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: April 25, 2021 Received: May 10, 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
2
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,
Liqun Zhao -S
For Clarence W. Murray III, 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
3
Indications for Use
510(k) Number (if known) K211434
Device Name Nitrile Patient Examination Gloves
Indications for Use (Describe)
The Nitrile Patient Examination Gloves are non-sterile disposable devices intended for medical purposes that are worn on the examiner's hands 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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4
510(k) Summary (K211434)
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Zhangjiagang Huayuan Protective Equipment Co., Ltd. Name: Address: No.333,Fumin Middle Road,Tanggiao town,Zhangjiagang City,Jiangsu,China Phone Number: +86-13705111918 Contact: Huamei Wang Date of Preparation: Aug.4,2021
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.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: Nitrile Patient Examination Gloves Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): XS、S、M、L、XL、XXL
3.0 Classification
Production code: LZA Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital
4.0 Predicate Device Information
Manufacturer: Ever Global (Vietnam) Enterprise Corp Device: Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color 510(k) number: K171422
5
5.0 Indication for Use
The Nitrile Patient Examination Gloves are non-sterile disposable devices intended for medical purposes that are worn on the examiner's hands or finger to prevent contamination between patient and examiner.
6.0 Device Description
The subject device is powder free nitrile examination gloves. The glove is manufactured from nitrile. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand. The subject device is blue. The subject device is non-sterile, and single use device to prevent contamination between patient and examiner.
The subject device can be available in six specifications: XS、S、M、L、XL and XXL.
| Table1-General Comparison | |||
|---|---|---|---|
| Item | Subject Device | ||
| (K211434) | Predicate Device | ||
| (K171422) | Remark | ||
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use/ | |||
| Indication for Use | The Nitrile Patient | ||
| Examination Gloves | |||
| are non-sterile | |||
| disposable devices | |||
| intended for medical | |||
| purposes that are | |||
| worn on the | |||
| examiner's hands or | |||
| finger to prevent | |||
| contamination | |||
| between patient and | |||
| examiner. | The Nitrile Powder | ||
| Free patient | |||
| examination glove | |||
| is a non-sterile | |||
| disposable device | |||
| intended for | |||
| medical purposes | |||
| that is worn on the | |||
| examiner's hands | |||
| or finger to prevent | |||
| contamination | |||
| between patient | |||
| and examiner. | Same | ||
| Powdered or | |||
| Powered free | Powdered or | ||
| Powered free | Powdered free | Same | |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Labeling Information | Single-use | Single-use | Same |
7.0 Technological Characteristic Comparison Table
6
| indication, powder | indication, powder |
|---|---|
| free, device color, | free, device color, |
| device name, glove | device name, glove |
| size and quantity, | size and quantity, |
| Nitrile Glove | Disposable Powder |
| Powder Free, Blue, | Free Nitrile |
| Non-Sterile | Examination Glove, |
| Non-Sterile |
Table2 Device Dimensions Comparison
| Designation | Size | Tolerance | ||||||
|---|---|---|---|---|---|---|---|---|
| Predicate | ||||||||
| Device(K171422) | Length, mm | XS | ||||||
| 230 | S | |||||||
| 230 | M | |||||||
| 230 | L | |||||||
| 230 | XL | |||||||
| 230 | min | |||||||
| Width, mm | 75 | 85 | 95 | 105 | 115 | ±5 | ||
| Thickness, mm: | ||||||||
| Finger | 0.05 | min | ||||||
| Palm | 0.05 | min | ||||||
| Subject | ||||||||
| Device(K211434) | Designation | Size | Tolerance | |||||
| Length, mm | XS | |||||||
| 220 | S | |||||||
| 220 | M | |||||||
| 230 | L | |||||||
| 230 | XL | |||||||
| 230 | XXL | |||||||
| 230 | min | |||||||
| Width, mm | 70 | 80 | 95 | 110 | 120 | 130 | ±10 | |
| Thickness, mm: | ||||||||
| Finger | 0.05 | min | ||||||
| Palm | 0.05 | min | ||||||
| Remark | Similar |
Analysis: The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D6319-19, so the differences do not raise any new safety or performance questions.
Table3 Performance Comparison
| Item | Subject device
(K211434) | Predicate device
(K171422) | Remark | | |
|------------------------|-----------------------------|-------------------------------|------------|------------|------|
| Colorant | Blue | White/ Blue/
Black/ Pink | Same | | |
| Physical
Properties | Before
Aging | Tensile Strength | 14MPa, min | 14MPa, min | Same |
| | | Ultimate Elongation | 500% min | 500% min | Same |
| | After
Aging | Tensile Strength | 14MPa, min | 14MPa, min | Same |
| | | Ultimate Elongation | 400%min | 400%min | Same |
7
| | Comply with ASTM D6319 | | Comply with
ASTM
D6319 | Same |
|--------------------|------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|------|
| 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 | Same |
| Powder Content | | Meet the
requirements
of ASTM
D6124 | Meet the
requirements
of ASTM
D6124 | Same |
Table4 Safety Comparison
| | | Subject
device
(K211434) | Predicated
device
(K171422) | Remark |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-----------------------------------|--------|
| Material | | Nitrile | Nitrile | Same |
| Biocompatibility | Irritation (ISO
10993-10:2010
Biological
Evaluation of
Medical Devices -
Part 10: Tests For
Irritation And Skin
Sensitization) | Under the
conditions of
the study, not
an irritant | | |
| | Sensitization
(ISO 10993-
10:2010
Biological
Evaluation of
Medical Devices -
Part 10: Tests For
Irritation And Skin
Sensitization) | Under
conditions of
the study, not
a sensitizer. | Comply with
ISO10993-
10 | Same |
| | Cytotoxicity (ISO
10993-5:2009
Biological
Evaluation of
Medical Devices -
Part 5: Tests For
In Vitro) | Under
conditions of
the study,
device
extract is not
cytotoxic | / | / |
8
| (
| Citotoxicity) |
|---|
| -------------------- |
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 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
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 D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
| Test
| Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319 | Physical | ||
| Dimensions | |||
| Test | Length(mm): | ||
| XS/S:≥220; | |||
| M/L/XL: ≥230. | Length: >230 | ||
| Width(mm): | Width: | ||
| XS: 70±10; | XS: 78-80 | ||
| S: 80±10; | S: 86-89 | ||
| M: 95±10; | M: 97-99 | ||
| L: 110±10; | L: 117-119 | ||
| XL: 120±10; | XL: 116-118 | ||
| XXL: 130±10 | XXL:128-131 | ||
| Pass | |||
| Thickness (mm): | XS: | ||
| Finger: ≥0.05 | |||
| Palm: ≥0.05 | Finger: 0.08-0.10 | ||
| Palm: 0.07-0.09 | |||
| S: | |||
| Finger: 0.07-0.11 | |||
| Palm: 0.07-0.09 | |||
| M: | |||
| Finger: 0.08-0.13 | |||
| Palm: 0.08-0.10 |
9
| L: | |||||
|---|---|---|---|---|---|
| Finger: 0.09-0.13 | |||||
| Palm: 0.08-0.11 | |||||
| XL: | |||||
| Finger: 0.08-0.11 | |||||
| Palm: 0.07-0.11 | |||||
| XXL: | |||||
| Finger: 0.08-0.10 | |||||
| Palm: 0.07-0.11 | |||||
| Pass | |||||
| ASTM D5151 | Watertightness | ||||
| Test for | |||||
| Detection of | |||||
| Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 2/125,0/125, | |||
| 0/125,1/125, | |||||
| 0/125,0/125 leaks | |||||
| Pass | |||||
| ASTM D6124 | Powder | ||||
| Content | Meet the requirements of ASTM D6124 |