(62 days)
Not Found
No
The device is a disposable glove and the description and performance studies do not mention any AI/ML components or functionalities.
No.
The "Intended Use" states that the device is "worn on the examiner's hands to prevent contamination between patient and examiner," which describes a barrier device, not a device for treating a disease or condition.
No
Explanation: The device is a nitrile glove, which is used for protection and to prevent contamination. It does not perform any diagnostic function.
No
The device is a physical glove, not software. The description clearly states it is a "disposable device intended purposes that is worn on the examiner's hands" and describes it as "Powder Free Nitrile Examination Gloves."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be worn on the examiner's hands to prevent contamination between patient and examiner. This is a barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: It's described as an examination glove, which is a physical barrier device.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
- Performance Studies: The performance studies focus on physical properties and biocompatibility (ISO 10993 standards), which are typical for barrier devices, not diagnostic accuracy metrics like sensitivity or specificity.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This glove does not fit that description.
N/A
Intended Use / Indications for Use
The Nitrile Glove Powder Free Black 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)
LZA
Device Description
The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is black. The proposed 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 / 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 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 D5151-06 (Reapproved2015), Standard Test Method for Detection of Holes in Medical Gloves.
D6319-10(Reapproved 2015), Standard Specification For Nitrile Examination Gloves For Medical Application.
Clinical testing is not needed for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Physical Properties:
Before Aging: Tensile Strength: 14MPa, min; Ultimate Elongation: 500% min
After Aging: Tensile Strength: 14MPa, min; Ultimate Elongation: 400% min
Freedom from Holes: Be free from holes when tested in accordance with ASTMD5151 AQL=2.5
Powder Content: 0.48 mg per glove
Biocompatibility:
Irritation: Under the conditions of the study, not an irritant
Sensitization: Under conditions of the study, not a sensitizer.
Cytotoxicity: Under conditions of the study, did not show potential toxicity to L-929 cells.
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). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
November 15, 2018
Haining Medical Products Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738, Shangcheng Rd., Pudong Shanghai, 200120 Cn
Re: K182528
Trade/Device Name: Nitrile Glove Powder Free Black Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: September 7, 2018 Received: September 14, 2018
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 lii III -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182528
Device Name Nitrile Glove Powder Free Black
Indications for Use (Describe)
The Nitrile Glove Powder Free Black is a disposable device intended 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 K182528
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Name: Haining Medical Products Co.,Ltd. Address: West Of Dianchang Road,Luannan County, Tangshan City , Hebei Province , 063500 China Phone Number: +86-315-4167693 Contact: Zhiming Yao Date of Preparation: Nov.7, 2018
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device information
Trade name: Nitrile Glove Powder Free Black Common name: Patient Examination Glove Classification name: Non-powdered patient examination glove Model(s): XS, S, M, L, XL
3.0 Classification
Production code: LZA Regulation number: 21 CFR 880.6250 Classification: Class I Panel: General Hospital
4.0 Predicate device information
4
| Manufacturer: | Ever Global (Vietnam) Enterprise Corp |
|---|---|
| Device: | Disposable Powder Free Nitrile Examination Glove, White/ |
| Blue/ Black/ Pink Color | |
| 510(k) number: | K171422 |
5.0 Indication for Use
The Nitrile Glove Powder Free Black 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 proposed device is Powder Free Nitrile Examination Gloves. The proposed device is black. The proposed device is non-sterile.
7.0 Technological Characteristic Comparison Table
| Item | Proposed device | Predicated device | Comparison |
|---|---|---|---|
| 510(k) number | K182528 | K171422 | |
| Product Code | LZA | LZA | Same |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Nitrile Glove | ||
| Powder Free | |||
| Black is a | |||
| disposable device | |||
| intended for | |||
| medical purposes | |||
| that is worn on the | |||
| examiner's hands | |||
| to prevent | |||
| contamination | |||
| between patient | |||
| and examiner. | The Disposable | ||
| Powder Free | |||
| Nitrile | |||
| Examination | |||
| Glove, White/ | |||
| Blue/ Black/ Pink | |||
| Color is a | |||
| disposable | |||
| device intended | |||
| for medical | |||
| purposes that is | |||
| worn on the | |||
| examiner's | |||
| hands to prevent | |||
| contamination | |||
| between patient | |||
| and examiner. | Same | ||
| Powdered or | Powdered free | Powdered free | Same |
Table 1-General Comparison
5
| Powered free | |||
|---|---|---|---|
| Design Feature | ambidextrous | ambidextrous | Same |
| Labeling Information | Single-use indication, powder free, device color, device name, glove size and quantity, Nitrile Glove Powder Free Black, Non-Sterile | Single-use indication, powder free, device color, device name, glove size and quantity, Disposable Powder Free Nitrile Examination Glove, Non-Sterile | Same |
Table 2 Device Dimensions Comparison
| Predicate
| Device(K171422) | Designation | Size | Tolerance | ||||
|---|---|---|---|---|---|---|---|
| XS | S | M | L | XL | |||
| Length, mm | 230 | 230 | 230 | 230 | 230 | min | |
| Width, mm | 75 | 85 | 95 | 105 | 115 | ±5 | |
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.05 | min | |||||
| Proposed Device | |||||||
| (K182528) | Designation | Size | Tolerance | ||||
| XS | S | M | L | XL | |||
| Length, mm | 230 | 230 | 230 | 230 | 230 | min | |
| Width, mm | 75 | 85 | 95 | 105 | 115 | ±5 | |
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.05 | min | |||||
| Comparison | SAME |
Table 3 Performance Comparison
| Item | Proposed device (K182528) | Predicated device (K171422) | Comparison | ||
|---|---|---|---|---|---|
| Colorant | Black | White/ Blue/ Black/ Pink | Analysis 1 | ||
| Physical Properties | Before Aging | Tensile Strength | 14MPa, min | 14MPa, min | Same |
| Ultimate | 500% min | 500% min | Same |
6
| | | Elongation
Tensile
Strength | 14MPa, min | 14MPa, min | Same |
|--|------------------------|-----------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|---------|
| | After
Aging | Ultimate
Elongation | 400% min | 400% min | Same |
| | Comply with ASTM D6319 | | 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 | | 0.48 mg per
glove | Meet the
requirements
of ASTM
D6124 | Similar |
Analysis 1: The proposed device has different color to the predicate device.
| Table 4 Safety Comparison | |
|---|---|
| --------------------------- | -- |
| Item | | Proposed
device
(K182528) | 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 | Under the
conditions of
the study, not
an irritant | Same |
| | Sensitization
(ISO 10993-
10:2010
Biological
Evaluation of
Medical
Devices - | Under
conditions of the
study, not a
sensitizer. | Under
conditions of
the study, not
a sensitizer. | |
7
| Part 10:
Tests For
Irritation And
Skin
| Sensitization) | |||
|---|---|---|---|
| Cytotoxicity | |||
| (ISO 10993- | |||
| 5:2009 | |||
| Biological | |||
| Evaluation of | |||
| Medical | |||
| Devices - | |||
| Part 5: Tests | |||
| For In Vitro | |||
| Cytotoxicity) | Under | ||
| conditions of the | |||
| study, did not | |||
| show potential | |||
| toxicity to L-929 | |||
| cells. | / | Similar |
8.0 Discussion of non-clinical and clinical test performed
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 D5151-06 (Reapproved2015), Standard Test Method for Detection of Holes in Medical Gloves.
D6319-10(Reapproved 2015), Standard Specification For Nitrile Examination Gloves For Medical Application.
Clinical testing is not needed for this device.
9.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicated device.