(96 days)
No
The device description and performance studies focus solely on the physical and material properties of a medical examination glove, with no mention of AI or ML technology.
No
The device is described as a disposable glove intended to prevent contamination between patient and examiner, not to treat or diagnose a medical condition.
No
The device is a medical exam glove, intended for preventing contamination, not for diagnosing medical conditions.
No
The device description clearly states it is a physical glove made of Nitrile Butadiene Rubber, designed and manufactured according to physical standards (ASTM D6319-10, etc.). There is no mention of software components or 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 "worn on the examiner's hand or fingers to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the physical properties and manufacturing process of a glove, designed for protection and ease of use. There is no mention of analyzing samples, detecting substances, or providing diagnostic information.
- Lack of Diagnostic Elements: The document does not mention any components or processes related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, DNA, antibodies, etc.)
- Providing information for diagnosis, monitoring, or treatment decisions.
- Performance Studies: The performance studies focus on the physical integrity, biocompatibility, and safety of the glove (water tightness, skin irritation, sensitization, toxicity). These are relevant to a medical device worn on the body, not an IVD.
In summary, the Showa® Medical Exam Glove is a medical device intended for barrier protection, not for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
The Showa® Medical Exam Glove (Green) Powder-free, Disposable Nitrile Glove is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
Product codes
LZC
Device Description
The Showa® Medical Exam Glove (Green) Powder-free, Disposable Nitrile Glove is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. The gloves are single use only, supplied in a nonsterile state, and come in six (6) sizes: XS, S, M, L, XL, and XXL.
The gloves are made of Nitrile Butadiene Rubber, designed, and manufactured in accordance with ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.
Their physical and performance characteristics meet all requirements of ASTM D6319-10. The gloves are powder-free and meet the requirements of ASTM D6124-06. No powder is used during any stage of manufacturing. Rather, the gloves are manufactured using online chlorination - a process wherein the examination gloves are dipped in a dilute chlorine solution to reduce surface friction. More specifically, through the chlorination reaction, the compound is stabilized and further cross-linked and the gloves' surface becomes hardened and smooth, thereby providing the gloves with good donning properties. The gloves then are removed from the chlorination solution and neutralized in an aqueous ammonia solution and washed until any residual chlorine is removed, resulting in the gloves' surface pH being similar to that of water. Once the wash process is completed, the reactive material is removed, thus ceasing the chlorination process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand or fingers
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
Non-Clinical Testing:
- Conforms to ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application
- Conforms to ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves
- Conforms to ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves
- Conforms to ASTM D7160-16 Standard Practice for Determination of Expiration Dating for Medical Gloves
- Conforms to ASTM D412-15a Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
Water Tightness:
- Conforms to ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves
- Conforms to ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application
- Conforms to ASTM D7160-16 Standard Practice for Determination of Expiration Dating for Medical Gloves
Biocompatibility Studies (ISO 10993-10, ISO 10993-11):
- ISO Skin irritation Study (ISO 10993-10): Under the conditions of the study, the non-polar and polar device extracts did not elicit a response in the animal model. Therefore, the device is not a skin irritant.
- ISO Closed Patch Sensitization Study (ISO 10993-10): Under the conditions of the study, the non-polar and polar device extracts did not elicit a response in the animal model. Therefore, the device is not a contact sensitizer.
- Acute Systemic Toxicity Study (ISO 10993-11): Under conditions of the ISO Acute Systemic Injection Test, the non-polar and polar device extracts did not elicit a response in the animal model. Therefore, the device does not present an acute toxicity potential.
Key results: Based on the Indication for Use, technological characteristics, and non-clinical performance data, Showa® Medical Exam Glove (Green) Powder-free, Disposable Nitrile Glove (K190159) is as safe, as effective, and performs as well as or better than the legally marketed predicate device (K082125).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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May 6, 2019
Showa Best Glove, Inc. % Lee Rosebush Attorney BakerHostetler 1050 Connecticut Avenue, NW, Suite 1100 Washington, District of Columbia 20036-5304
Re: K190159
Trade/Device Name: Showa® Medical Exam Glove (Green) Powder-free, Disposable Nitrile Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LZC Dated: January 28, 2019 Received: January 31, 2019
Dear Lee Rosebush:
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); 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,
For David Krause, PhD Acting Director Division of Infection Control and Plastic Surgery Office of Surgical & Infection Control Devices Office of Product Evaluation & Quality Center for Devices and Radiological Health
Enclosure
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| FOIA Exempt - Confidential and Trade Secret Information | |
|---|---|
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
| Food and Drug Administration | Form Approved: OMB No. 0910-0120 |
| Expiration Date: 06/30/2020 | |
| See PRA Statement below. |
Indications for Use
| 510(k) Number (if known) | K190159 |
|---|---|
| Device Name | Showa® Medical Exam Glove (Green) Powder-free, Disposable Nitrile Glove |
| Indications for Use (Describe) | The Showa® Medical Exam Glove (Green) Powder-free, Disposable Nitrile Glove is a disposable device intended for |
| medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. |
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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| FORM FDA 3881 (7/17) | Page 1 of 1 |
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510(k) Summary K190159
Image /page/3/Picture/1 description: The image shows the SHOWA logo with the text "Revised 510(k) Date: March 26, 2019" underneath. The SHOWA logo is in black and green. The text is in black and is centered below the logo.
General Information
Submitter: I.
- Name: Showa Best Glove, Inc. a.
- b. Address: 579 Edison Street, Menlo, GA 30731-6335
- Telephone Number: 706-862-6712 C.
- d. Fax Number: 706-862-6000
- Contact Person: Jeffrey Richardson e.
- f. FDA Owner/Operator Number: 9041216
Name of Device: II.
- Trade or Proprietary Name: Showa® Medical Exam Glove (Green) Powder-free, a. Disposable Nitrile Gloves
- b. Common or Usual Name: Polymer Patient Exam Gloves
- Classification Name: Patient Examination Glove (LZA, 21 C.F.R. § 880.6250) C.
- d. 510(k) Submission Number: K190159
III. Predicate Device:
- a. Name: N-DEX NightHawk® Black Nitrile Powder-Free Medical Examination Glove (Black), Non-Sterile
- b. Submission Number: K082125
IV. Description of Device:
The Showa® Medical Exam Glove (Green) Powder-free, Disposable Nitrile Glove is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent
4
contamination between patient and examiner. The gloves are single use only, supplied in a nonsterile state, and come in six (6) sizes: XS, S, M, L, XL, and XXL.
The gloves are made of Nitrile Butadiene Rubber, designed, and manufactured in accordance with ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.
Their physical and performance characteristics meet all requirements of ASTM D6319-10. The gloves are powder-free and meet the requirements of ASTM D6124-06. No powder is used during any stage of manufacturing. Rather, the gloves are manufactured using online chlorination - a process wherein the examination gloves are dipped in a dilute chlorine solution to reduce surface friction. More specifically, through the chlorination reaction, the compound is stabilized and further cross-linked and the gloves' surface becomes hardened and smooth, thereby providing the gloves with good donning properties. The gloves then are removed from the chlorination solution and neutralized in an aqueous ammonia solution and washed until any residual chlorine is removed, resulting in the gloves' surface pH being similar to that of water. Once the wash process is completed, the reactive material is removed, thus ceasing the chlorination process.
| Characteristic | Predicate Device
K082125 | Proposed Device
K190159 | Comparison |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | N-DEX NightHawk®
Black Nitrile Powder-
Free Medical
Examination Glove
(Black), Non-Sterile | Showa® Medical
Exam Glove
(Green) powder-
free, disposable
nitrile gloves | |
| Device Description/
Regulation Number | Patient examination
glove/ 21 C.F.R. §
880.6250 | Patient examination
glove/ 21 C.F.R. §
880.6250 | Identical |
| Product Code | LZA | LZA | Identical |
| Intended Use | Intended for medical
purposes that is worn
on the examiner's
hand to prevent
contamination
between patient and
examiner. | Intended for medical
purposes that is worn
on the examiner's
hand to prevent
contamination
between patient and
examiner. | Identical |
Technological Characteristic Comparison Table:
5
| Instructions for Use | A disposable device
intended for medical
purposes that is worn
on the examiner's
hand to prevent
contamination
between patient and
examiner. | A disposable device
intended for medical
purposes that is worn
on the examiner's
hand to prevent
contamination
between patient and
examiner. | Identical |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Materials | Nitrile | Nitrile | Identical |
| Color | Black | Green | Different |
| Single Use | Yes | Yes | Identical |
| Physical Property | Meets ASTM D6319-
00 | Meets ASTM D6319-
00 | Identical |
| Powder Residual | Meets ASTM D6124
of