(207 days)
Nitrile Powder Free Patient Examination Gloves, Blue color 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.
Nitrile films form a barrier to body fluids and bloodborne Pathogens. 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. Nitrile glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.
The provided document is a 510(k) summary for Nitrile Powder Free Patient Examination Gloves, Blue Color. This document describes the device's characteristics and its comparison to a predicate device to establish substantial equivalence, not a study performing extensive clinical trials typically associated with AI/ML devices. Therefore, many of the requested criteria regarding AI device performance are not applicable to this submission.
Here's an analysis of the provided information relative to your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally based on meeting established ASTM and CFR standards.
| Characteristic | Standard/Acceptance Criteria | Device Performance |
|---|---|---|
| Dimension | ASTM D 6319-10 | Meets |
| Physical Properties | ASTM D 6319-10 (Before/After aging: Elongation $\ge$ 500%, Tensile Strength $\ge$ 14MPa) | Meets (Elongation: 520-580%, Tensile Strength: 22-34 MPa) |
| Freedom from pinholes | 21 CFR 800.20, ASTM D 5151-06 (Reapproved 2011), AQL 2.5 (Inspection Level I) | Meets |
| Powder Residual | ASTM D 6319-10, ASTM D 6124-06 (Reapproved 2011) | Meets (< 2mg/glove) |
| Biocompatibility | Primary Skin Irritation (ISO 10993-10: 2010-08-01) | Passes (Not a Primary Skin Irritation) |
| Dermal Sensitization (ISO 10993-10: 2010-08-01) | Passes (Not a Dermal Sensitization) | |
| Length | ASTM D6319-10 ($ \ge \text{230mm min}$) | 230mm min for all sizes |
| Width | ASTM D6319-10 (Small 70-90mm, Medium 85-105mm, Large 100-120mm, Xlarge 110-130mm) | Small 84-86mm, Medium 94-97mm, Large 104-109mm, Xlarge 114-119mm |
| Thickness | ASTM D6319-10 (Finger 0.05mm min, Palm 0.05mm min) | Finger 0.10mm min, Palm 0.06mm min |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each test (e.g., how many gloves were tested for pinholes, or how many rabbits/guinea pigs for biocompatibility). The testing is described generally as meeting ASTM and ISO standards. The data provenance is implied to be from the manufacturer's testing facilities in China (Submitter's address: Xigaozhuang, Pachigang Town, Luannan County, Hebei Province, 063502, China). The studies are "non-clinical performance data" and are retrospective in the sense that they were conducted for the purpose of this submission, not as a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided. For this type of device (patient examination gloves), "ground truth" would typically refer to objective measurements and chemical/physical analyses performed by qualified laboratory technicians and specialists, rather than clinical experts or radiologists. The document references specific ASTM and ISO standards, which dictate the methodology for these tests.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method. The tests are based on objective pass/fail criteria according to established standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This type of study is typically performed for diagnostic imaging devices where human readers interpret results. This is a purely physical/chemical performance device (patient examination glove) and not an AI/ML diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This question is not applicable as the device is a physical medical glove and does not involve an algorithm or AI.
7. The Type of Ground Truth Used
The ground truth is based on objective measurements and laboratory testing defined by recognized international and national standards:
- ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- 21 CFR 800.20 (Regulations for pinhole testing)
- ASTM D5151-06 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124-06 (Standard Test Method for Residual Powder on Medical Gloves)
- ISO 10993-10:2010 (Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization)
8. The Sample Size for the Training Set
This question is not applicable. The device is not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for this device.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-000
December 12, 2014
Yongxin Healthcare Co., Ltd. C/O Mr. Chu Xiaoan Room 1606 Bldg.1. Jianxiang Yuan No. 209 Bei Si Huan Zhong Road Haidian District Beijing, 100083 CHINA
Re: K141304
Trade/Device Name: Nitrile Powder Free Patient Examination Gloves, Blue Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: October 28, 2014 Received: October 30, 2014
Dear Mr. Xiaoan,
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. 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.
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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K141304
Device Name
Nitrile Powder Free Patient Examination Gloves, Blue Color
Indications for Use (Describe)
Nitrile Powder Free Patient Examination Gloves, Blue Color 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.
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 6 510(k) Summary
510(K) Summary
"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."
= "The assigned 510(k) number is: K141304
Premarket Notification [510(k)] Summary
1.0 Submitter:
| Submitter's name : | Yongxin Healthcare Co., Ltd. |
|---|---|
| Submitter's address : | Xigaozhuang, Pachigang Town, LuannanCounty, Hebei Province, 063502, China |
| Phone number : | (86) 315-4169201 |
| Fax number : | (86) 315-4430333 |
| Name of contact person: | Zhang Liang |
| Date of preparation : | 2014-12-08 |
2.0 Name of the Device
| Device Name: | Nitrile Powder Free Patient ExaminationGloves, Blue color |
|---|---|
| Proprietary/Trade name: | Nitrile Powder Free Patient ExaminationGloves, Blue color |
| Common Name: | Patient exam gloves |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital (80) |
| Product Code: | LZA |
3.0 Predicate device
| Device Name: | Nitrile Power Free Patient Examination Gloves,Coloured (Blue) |
|---|---|
| Company name: | Tangshan Zhonghong Pulin Plastic Co.,Ltd. |
| 510(K) Number: | K120970 |
4.0 Device Description:
- 4.1 How the device functions:
Nitrile films form a barrier to body fluids and bloodborne Pathogens
4.2 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
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medical procedure.
4.3 Physical and performance characteristics such as design, materials and physical properties:
Nitrile glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.
5.0 Device Intended Use (Indication for use):
Nitrile Powder Free Patient Examination Gloves, Blue color 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.
6.0 Summary of the Technological Characteristics of the Device:
The Nitrile Powder Free Patient Examination Gloves, Blue color, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Characteristics | Standard | Device performance |
|---|---|---|
| Dimension | ASTM standard D 6319-10. | Meets |
| Physical Properties | ASTM standard D 6319-10. | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 6319-10 andD6124-06(Reapproved 2011). | Meets<2mg/glove |
| Biocompatibility | Primary Skin Irritation in rabbitsISO 10993-10: Third Edition2010-08-01. | PassesNot a Primary SkinIrritation |
| Dermal sensitization in theguinea pig ISO 10993-10: ThirdEdition 2010-08-01. | PassesNot a Dermalsensitization |
7.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data:
Nitrile Powder Free Patient Examination Gloves, Blue color, meet requirements per ASTM D6319-10.per ASTM D6124-06(Reapproved 2011), per 21 CFR 800.20 and ISO 10993-10: Third Edition 2010-08-01.
The performance test data of the non clinical tests that support a determination of substantial equivalent is the same as mentioned immediately above.
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8.0 Substantial Equivalent Based on Assessment of Clinical Performance Data:
Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
| 9.0 Substantial Equivalence Comparison: | |||
|---|---|---|---|
| Features & Description | Predicate Device | Subject Device | Result of Comparison |
| Company | Tangshan Zhonghong PulinPlastic Co.,Ltd. | Yongxin Healthcare Co., Ltd. | -- |
| 510(K) Number | K120970 | K141304 | |
| Product name | Nitrile Power Free PatientExamination Gloves,Coloured (Blue) | Nitrile Powder Free PatientExamination Gloves, Blue color | same |
| Product Code | LZA | LZA | same |
| Size | Small/ Medium/Large/X large | Small/ Medium/Large/X large | same |
| Intend for use | Nitrile Power Free PatientExamination Gloves,Coloured (Blue) is adisposable device intendedfor medical purposes that isworn on the examiner's handor finger to preventcontamination betweenpatient and examiner. | Nitrile Powder Free PatientExamination Gloves, Blue color isa disposable device intended formedical purposes that is worn onthe examiner's hand or finger toprevent contamination betweenpatient and examiner. | Similar |
| DeviceDescription andSpecifications | Meets ASTM D6319-10 | Meets ASTM D6319-10 | Similar |
| Dimensions--Length | Meets ASTMD6319-10$≥$ 230mm min | 230mm min for all sizes | Similar |
| Dimensions-- Width | Meets ASTM D6319-10Small 70-90 mmMedium 85-105mmLarge 100-120mmXlarge 110-130 mm | Small 84-86 mmMedium 94-97mmLarge 104-109mmX large 114-119 mm | Similar |
| Dimensions--Thickness | Meets ASTM D6319-10Finger 0.05mm min.Palm 0.05mm min. | Thickness (mm) min.Finger 0.10 mm min.Palm 0.06 mm min. | Similar |
| PhysicalProperties | Meets ASTM D D6319-10Before aging/after aging | Before aging/after aging | Similar |
| Elongation $≥$ 500%Tensile Strength $≥$ 14MPa | Elongation :520-580%Tensile Strength:22-34 MPa | ||
| FreedomfromPinholes | Meets• 21 CFR 800.20• ASTM D6319-10• ASTM D 5151-06(Reapproved 2011) | Meets ASTMD5151-06(Reapproved 2011)Holes atInspection Level IAQL2.5 | Similar |
| Residual | Meets ASTM | Meets ASTM | Similar |
| Powder | D 6124-06(Reapproved 2011)below 2mg of residualpowder | D 6124-06(Reapproved 2011)Results generated values below2mg of residual powder | |
| Materials usedto fabricate thedevices | Nitrile | Nitrile | Similar |
| Dusting orDonningPowder: | PU | PU | Similar |
| Dusting orDonningPowder: name | PU | Surface Coating Agent | Similar |
| Compareperformancedata supportingsubstantialequivalence | MeetsASTM D5151-06(Reapproved 2011)ASTM D6319-10ASTM D6124-06(Reapproved 2011) | MeetsASTM D5151-06(Reapproved 2011)ASTM D6319-10ASTM D6124-06(Reapproved 2011) | Similar |
| Single PatientUse | Single Patient Use | Single Patient Use | Similar |
| Biocompatibility | SKIN IRRITATIONDERMAL andSENSITIZATIONSTUDIES Meets ISO10993-10:2002/Amd.1:2006 | SKIN IRRITATION DERMALand SENSITIZATION STUDIESMeets ISO 10993-10: ThirdEdition 2010-08-01.Under the conditions of thestudy, not an irritant and underconditions of the study, not asensitizer. | Similar |
| Labeling for thelegally marketeddevice to whichsubstantialequivalence isclaimed. | -Powder Free-Patient Examination Glove-Single Use Only- Manufactured For:- Lot-Blue color- Non sterile | -Powder Free-Patient Examination Glove-Single Use Only- Manufactured For:- Lot-Blue color- Non sterile | Similar |
Substantial Equivalence Comparison: 9.0
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10.0 Substantial Equivalence Comparison:
It can be concluded that the Nitrile Powder Free Patient Examination Gloves, Blue color meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims.
It can be concluded that the Nitrile Powder Free Patient Examination Gloves, Blue color is as safe, as effective, and performs as well as the predicate device, Nitrile Power Free Patient Examination Gloves, Coloured (Blue), Tangshan Zhonghong Pulin Plastic Co. ,Ltd.. K120970.
The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device.
§ 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.