(141 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of examination gloves, with no mention of AI or ML.
No.
The device description indicates it is an examination glove worn to prevent contamination between patient and examiner, which is a barrier function, not a therapeutic intervention.
No
The device is described as an examination glove intended to prevent contamination, not to diagnose any condition. The "Intended Use" and "Device Description" sections clearly state its purpose for protection and hygiene, with no mention of diagnostic capabilities.
No
The device is a physical examination glove, not a software application. The description focuses on the physical properties and performance of the glove.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "patient examination glove" worn on the hand to prevent contamination between patient and examiner. This is a barrier device for physical protection.
- Device Description: The description reinforces the intended use as a disposable glove for healthcare personnel to prevent contamination. The technological characteristics listed relate to the physical properties of the glove (dimensions, physical properties, freedom from pinholes, powder-free).
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
- Performance Studies: The performance studies described focus on the physical properties and biocompatibility of the glove, not on the analysis of biological samples.
Therefore, this device falls under the category of a medical device used for barrier protection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A patient examination glove is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LYZ
Device Description
The powder-free vinyl exam gloves are disposable devices intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare and similar personnel
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)
Biocompatibility testing was conducted to ISO 10993, "Biological Evaluation of Medical Devices", Part 10, "Tests for Irritation and Sensitization" and Part 11, "Tests for Systemic Toxicity(ISO)".
ISO Skin Irritation Study on Rabbit: Passed
Murine Local Lymph Node Assay (LLNA) on Mouse: Passed
USP and ISO Systemic Toxicity Study Extract on Mouse: Passed
Clinical data are not needed for examination gloves.
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.
Not Found
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
SAFESKIN* BLUE ZONE Powder-Free Vinyl Exam Glove
OCT 2 4 2003
erly-Clark Corporation
FALTH CARE SECTOR 00 Holcomb Bridge Road oswell GA 30076-2199
Phone: (770) 587-8000 Fax: (770) 587-7762
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
- 510(k) Summary of Safety and Effectiveness Information [1]
- Kimberly-Clark Corporation [2] 1400 Holcomb Bridge Road Roswell, GA 30076-2199 770-587-8000 Telephone: Fax: 770-587-7762
Richard V. Wolfe Contact: Telephone: 770-587-8208 Fax: 770-587-7761
- SAFESKIN* BLUE ZONE Powder-Free Vinyl Exam Glove (3) Trade Name: Common Name: Patient Examination Gloves, Vinyl Classification Name: Patient Examination Gloves, Vinyl
- The predicate device is a Class I, powder-free vinyl exam glove 80L YZ that meets all of the [4] requirements of ASTM D 5250-00, "Standard Specification for Poly(vinyl chloride) Gloves for Medical Application"
- The powder-free vinyl exam glove meets the current specifications of ASTM D 5250-00. [૨] "Standard Specification for Poly(vinyl chloride) Gloves for Medical Application"
- The powder-free vinyl exam gloves are disposable devices intended to be worn by healthcare [6] and similar personnel to prevent contamination between such personnel and the patient.
Attachment H (page 1 of 2)
1
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION (Cont'd)
- The powder-free vinyl exam gloves possess the following technological characteristics (as [7] compared to ASTM or equivalent standards):
| Characteristics | Standards |
|---|---|
| Dimensions | Meets ASTM D 5250-00 |
| Physical Properties | Meets ASTM D 5250-00 |
| Freedom from pinholes | Meets ASTM D 5250-00 |
| Meets ASTM D 5151-99 | |
| Powder Free | Meets ASTM D 6124-01 |
| Meets ASTM D 5250-00 |
Biocompatibility - Biocompatibility testing was conducted to the following parts of ISO 10993, "Biological Evaluation of Medical Devices":
- Part 10, "Tests for Irritation and Sensitization" ●
- Part 11, "Tests for Systemic Toxicity(ISO): ●
| Study Title | Test Animal | Results |
|---|---|---|
| ISO Skin Irritation Study | Rabbit | Passed |
| Murine Local Lymph Node Assay (LLNA) | Mouse | Passed |
| USP and ISO Systemic Toxicity Study Extract | Mouse | Passed |
- [8] The performance test data that support a determination of substantial equivalence are described above.
- ી છે Clinical data are not needed for examination gloves.
- It can be concluded that the powder-free vinyl exam glove is safe and effective and will [10] perform according to the glove performance standards referenced in Section 7 above, thereby meeting ASTM standards, FDA requirements, and the labeling claims for the product. Consequently, this exam glove is substantially equivalent to currently marketed exam gloves.
Attachment H (page 2 of 2)
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, with a wing-like shape above them.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 4 2003
Mr. Richard V. Wolfe Manager, Regulatory Affairs Kimberly-Clark Corporation 1400 Holcomb Bridge Road Roswell, Georgia 30076
Re: K031750
Trade/Device Name: SAFESKIN* BLUE ZONE Powder-Free Vinyl Exam Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: LYZ Product Code: I Dated: August 14, 2003 Received: August 18, 2003
Dear Mr. Wolfe:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 -Mr. Wolfe
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Sina Runne
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/2 description: The image shows the logo of Kimberly-Clark Corporation. The logo consists of a circular symbol with a stylized "KC" inside, followed by the company name "Kimberly-Clark Corporation" in bold, sans-serif font. The logo is simple and professional, reflecting the company's established presence in the consumer goods industry.
HEALTH CARE SECTOR 1400 Holcomb Bridge Road Roswell, GA 30076-2199
Phone: (770) 587-8000 Fax: (770) 587-7762
DICATIONS FOR USE
| Applicant: | Kimberly-Clark Corporation |
|---|---|
| 510(k) Number: | K031750 |
| Device Name: | SAFESKIN* BLUE ZONE Powder-Free Vinyl Exam Glove |
| Indications for Use: | Based upon 21CFR§880.6250 “Patient examination glove”: |
| A patient examination glove is a medical device intended for medical |
A patient examination glove is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Patrice Ari, Lisen Branch Chief, IMCS 10/23/6
Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental D
510(k) Number: K031752
OR
Prescription Use Per 21CFR 801.109 Over-The-Counter
Attachment C