(51 days)
Not Found
Not Found
No
The device is a medical examination glove, which is a simple barrier device and does not involve any computational or analytical capabilities. The summary explicitly states "Not Found" for mentions of AI, DNN, or ML, and there is no description of training or test sets, which are typical for AI/ML devices.
No
The device, examination gloves, are used to prevent contamination between patient and examiner, not to treat or cure a disease or condition.
No
Explanation: This device is a medical examination glove, which is a barrier to prevent contamination, not a tool for diagnosis.
No
The device is a physical medical glove, not a software application. The description clearly states it is a "non-sterile disposable device intended for medical purposes that is worn on the examiners hand".
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 gloves are "worn on the examiners hand to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description reinforces the intended use as a barrier device worn on the hand.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information. The device's function is purely physical protection.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol are non-sterile disposable devices intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
80 LYY
Device Description
Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol are non-sterile disposable devices intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
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)
The performance test data of the non clinical tests are the same as mentioned immediately above. Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process. It is concluded that the Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol (Modified) are as safe, as effective, and perform as well as the glove performance standards referenced above and therefore meet: ASTM listed standards, FDA hole requirements, and labeling claims for the product.
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
Image /page/0/Picture/1 description: The image shows the logo for Ansell Professional Healthcare. The word "Ansell" is in large, bold, black letters, with a curved line underneath. Below that, the words "PROFESSIONAL HEALTHCARE" are in smaller, black letters.
NOV 1 3 2002
1875 Harsh Ave. S.E. • P.O. Box 550 Massillon, OH 44648-0550 U.S.A. 330.833.2811 / 800.321.9752 U.S.A. 330.833.5991 Fax ansellhealthcare.com
Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol Ansell Healthcare Products Inc. 1875 Harsh Avenue SE Massillon, Ohio 44646 Telephone: 330-833-2811 Fax: 330-833-6501
- [1] Summary
- Ansell Healthcare Products Inc. [2] 1875 Harsh Avenue SE Massillon, Ohio 44646
James R. Chatterton Contact: Telephone: 330-833-2811 Fax: 330-833-6501
September 18, 2002
- Trade Name: Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and [3] Glycerol Common Name: Examination Gloves Classification Name: Glove, Patient Examination, Latex
- Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol [4] meet all of the requirements of ASTM D 3578-01a22.
- [રી Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol meet all the current specifications for ASTM D 3578-01a €2 Rubber Examination Gloves.
- [[]] Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol are non-sterile disposable devices intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
- [7] Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| Characteristics | Standard |
|---|---|
| Dimensions | Meets ASTM D 3578-01a€2 |
| Physical Properties | Meets ASTM D 3578-01a€2 |
| Freedom from holes | Meets ASTM D 3578-01a€2 |
| Meets ASTM D 5151-99 | |
| Powder-Free | Meets ASTM D 3578-01a€2 |
| Not more than 2 mg residue by mass per | |
| glove. |
1
Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol Ansell Healthcare Products Inc. 1875 Harsh Avenue SE Massillon, Ohio 44646 Telephone: 330-833-2811 330-833-6501 Fax:
Biocompatability Primary Skin Irritation in Rabbits Guinea Pig Sensitization
Passes Passes
- (8) The performance test data of the non clinical tests are the same as mentioned immediately above.
- Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process. ləl
- [10] It is concluded that the Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol (Modified) are as safe, as effective, and perform as well as the glove performance standards referenced above and therefore meet:
ASTM listed standards, FDA hole requirements, and labeling claims for the product.
- [11] This summary will include any other information reasonably deemed necessary by the FDA.
2
Image /page/2/Picture/0 description: The image shows a partial view of a document or logo. On the left, there's a stylized graphic that appears to be a series of curved lines or shapes, possibly representing waves or a stylized symbol. To the right of this graphic, the word "DEPART" is visible, suggesting that the document or logo is related to a department or organization with a name starting with these letters. The overall image is cropped, so the full context and meaning are not immediately clear.
NOV 13 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. James R. Chatterton Vice President Regulatory Ansell Healthcare Products, Incorporated 1875 Harsh Avenue, S.E. · Massillon, Ohio 44646-7199
Re: K023153
Trade/Device Name: Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol (Green) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: 80 LYY Dated: October 25, 2002 Received: October 28, 2002
Dear Mr. Chatterton:
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. Chatterton
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours.
for Susan Penner
Timothy A. Ullatowski
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Number (if known)
KC 23153
Device Name
Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol (Green)
Indications for Use
Micro-Touch® Next Step™ Powder Free Medical Examination Gloves with Aloe and Glycerol intended for medical purposes that is worn on the examiners 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)
Prescription Use Per 21 CFR 801.109 OR
Over-The-Counter Use
Clins. Ps
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number. K023153