Medical Device

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Waiver Form
P: +1-757-224-0177 F: +1-757-224-0179 E: info@registrarcorp.com
Date: August 25, 2020

Attn: E Glove Sdn. Bhd

No 35, Jalan 15/23, Taman Perindustrian Tiong Nam
Section 15, Shah Alam Malaysia
Shah Alam, Selangor 40200
Malaysia

Re: Device Name : Polymer Patient Examination Glove Product Code: LZA
We write concerning your request to list a device in the referenced category with the U.S. Food and Drug Administration (“FDA”).
We are concerned that marketing of the product, its labeling or technology, may exceed the limitations of the applicable provision
of the Code of Federal Regulations, which is as follows for the referenced category, in pertinent part:
Sec. 880.6250 Non-powdered patient examination glove.
(a) Identification. A non-powdered patient examination g
love 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).
[45 FR 69682, Oct. 21, 1980, as amended at 54 FR 1604, Jan. 13, 1989; 66 FR 46952, Sept. 10, 2001; 81 FR 91730, Dec. 19,
2016]

We have recommended review of potential compliance issues concerning your product and its labeling prior to marketing it in
the referenced category. You have directed us to proceed with listing of your device with the FDA in the referenced category
without such a review by our firm, relying on your own legal counsel concerning the appropriate category for listing and
marketing of the device, the limitations thereof, and any and all potential labeling and other compliance issues; as it relates to
Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health
Emergency See https://www.fda.gov/media/136540/download

You agree to assume all risk, release Registrar Corp and its officers, directors, employees, affiliates and agents from any and all
liability in connection with this product and its listing, waive all claims and will hold harmless and indemnify Registrar Corp and
its officers, directors, employees, affiliates and agents from any and all claims in connection with this product, its marketing,
labeling or listing with FDA. If applicable, you acknowledge and agree to notify all importers of the signed waiver for this specific
product.
Please confirm that you have instructed Registrar Corp as your Official Correspondent to proceed to list this device, subject to
the conditions above, and sign in the space below to affirm that you understand and agree to the foregoing. Any previous waiver
of liability, indemnity or other agreement to hold harmless is confirmed and not reduced hereby.

Very truly yours,

David Lennarz
Registrar Corp

We understand and agree to the foregoing. Please proceed with listing of the device with the U.S. Food and Drug Administration
on behalf of our firm as set forth above.

By: Title: Chief Executive Officer

Signature

Print Name: Dato’ Mohammed Salim Date: 11/09/2020